186 Sdtm Jobs - Page 2

Location Bengaluru, Karnataka, India Job ID R-228434 Date posted 24/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! Date Posted 25-Jun-2025 Closing Date 29-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. ]]>

Location Bengaluru, Karnataka, India Job ID R-227889 Date posted 24/06/2025 Job Title: Principal Programmer - Statistical Programming Introduction to role: Are you ready to take on a pivotal role in statistical programming? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the creation of Tables, Listings, and Figures for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll lead programming efforts, represent Clinical and Statistical Programming in meetings, and mentor fellow programmers. This is your chance to integrate statistical concepts with SAS Programming efficiently and effectively! Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Oversee progress of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree (Preferred) in Biostatistics, Statistics or another related discipline Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge of: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, we play an essential role in helping patients who need it the most. Our high exposure roles allow us to shape end deliverables while embracing global opportunities across all Therapy Areas. With a restless drive for improvement, we foster an inspiring learning environment where every setback is a chance to innovate. Our courageous team speaks up, shares opinions, and makes bold decisions that could change patients' lives. We combine specialist knowledge with curiosity, always searching for better ways to achieve the best results. Here, dedication and motivation are key as we navigate unknowns with resilience. Ready to make an impact? Apply now to join our dynamic team! Date Posted 25-Jun-2025 Closing Date 29-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. ]]>

As a Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Skills required: define.xml, P21, SDRG, ADRG What You Will Be Doing The role is part of the Submissions Center of Exellence Will need to keep informed of the latest regulatory requirements The programming of SDTM datasets, ADaM datasets, and TFLs will still be the responsibility of the trial clinical/statistical programmer Qualifications Previous experience submitting data to regulatory authorities is preferred Will take on the post-database lock activities related to making SDTM and ADaM data packages submission-ready (per latest requirements) Resizing datasets, removing empty variables etc. Generating Define.pdf o Final P21E run Verifying all explanations are correct in the cSDRG/ADRG o Bookmarking and setting correct properties for PDF documents, etc. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Essential Functions: • Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically. • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies. • Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies. • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines. • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables. • Use and promote the use of established standards, SOP and best practices. • Provide training and mentoring to SP team members and Statistical Programming department staff. Qualifications: • Bachelor's Degree Maths, Computer science, Statistics or related field and 10 years relevant experience Req Or • Master's Degree Maths, Computer science, Statistics or related field and 12 years relevant experience Pref • Typically requires 7+ years of prior relevant experience • Equivalent combination of education, training and experience in lieu of degree • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. • Advanced knowledge of statistics, programming and/or clinical drug development process; • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language, where applicable • Excellent organizational, interpersonal, leadership and communication skills • Excellent accuracy and attention to detail • Aptitude for mathematical calculations and problem solving • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. Responsibilities How you will contribute: Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Submissions experience utilizing define.xml and other submission documents. Experience supporting immunology, respiratory or oncology studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable) Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Description. Principal Stat Programmer. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.. Works to ensure that outputs meet quality standards and project requirements.. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.. Keeps project team members informed of programming progress and issues requiring their attention.. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).. Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately definesall variables to be accepted by peer review and sponsor/requestor with little rework.. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programmingdeliverables.. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.. Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards. When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML). When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.. Transfers deliverables.. Performs other work-related duties as assigned.. Minimal travel may be required. Qualifications. Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred.. Experience in mentoring others in clinical trial process and CDISC Standards.. Excellent written and verbal communication skills.. Ability to read, write, speak and understand English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description Sr Statistical Programmer SDTM, ADAM & TLFs Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications, Works to ensure that outputs meet quality standards and project requirements, Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings, Keeps project team members informed of programming progress and issues requiring their attention, Follow applicable SOPs, WIs, and relevant regulatory guidelines (e-g ICH), Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness, Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload, Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines allvariables to be accepted by peer review and sponsor/requestor with little rework, Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others, Conducts effective internal meetings (appropriate in format, frequency and attendance) Distributes relevant information in advance Ensures minutes are promptly and accurately distributed Follows action items through to completion, and maintains order and focus of meetings, working toward consensus, Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business, Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted, Acts as the lead statistical programmer Directs the programming activities of other programming personnel and monitors progress on programming deliverables, Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities, Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor, Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Should have an experience of 5+ years in Clinical Statistical programming with expertise in end-to-end programming (SDTM, ADAM & TLGs), Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience, Extensive programming experience in SAS or other required software, preferably in a clinical trial environment, Excellent written and verbal communication skills, Ability to read, write, speak and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description Sr Stat Programmer (SDTM + ADAMs + TLF) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications, Works to ensure that outputs meet quality standards and project requirements, Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings, Keeps project team members informed of programming progress and issues requiring their attention, Follow applicable SOPs, WIs, and relevant regulatory guidelines (e-g ICH), Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness, Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload, Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately definesall variables to be accepted by peer review and sponsor/requestor with little rework, Conducts effective internal meetings (appropriate in format, frequency and attendance) Distributes relevant information in advance Ensures minutes are promptly and accurately distributed Follows action items through to completion, and maintains order and focus of meetings, working toward consensus, Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business, Accountable for on-time delivery across concurrent programming deliverables Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions, Acts as the lead statistical programmer Directs the programming activities of other programming personnel and monitors progress on programmingdeliverables, Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities, Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor, Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process, Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions, Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures, Contributes technical expertise to the development of programming tools and macros for standardization and efficiency, When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents (i-e DEFINE XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience, Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers, Knowledge and experience in the use of CDISC Standards for regulatory agency requirements Experience in submissions to a regulatory agency preferred, Experience in mentoring others in clinical trial process and CDISC Standards, Excellent written and verbal communication skills, Ability to read, write, speak and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show more Show less

Title - Associate Director - Data Product Manager GCL- E Typical Accountabilities: The role holder will execute the following accountabilities autonomously with limited supervisory oversight: Works with consumers / business users on the definition of the data requirements for intended data solutions. Able to translate unstructured, complex business problems into a data design and solution Profiling of data to understand provenance, quality, metadata models, ownership and compliance to internal and external regulatory standards Ad hoc wrangling of data (sourcing, extraction, profiling, integration) to support Data Science model generation and business insight Support of data engineers in the development of Source to Target pipelines (e.g. ETL design) Design & testing of the quality and performance of derivative data models in reporting and analytics solutions Processing of requests for compliant access to data Defining and managing information lifecycle management in data solutions Provision of data understanding (structure, provenance, quality) to Architects, Data Engineers and Data Scientists to support use in Analytics projects. Supports IT and business data teams in identifying and managing Critical Data Assets and Elements including Reference, Master and Metadata. Collaborates with Risk, Assurance, Privacy, Information Security and Regulatory authorities to ensure data and information controls are in place and adhered to. Clearly and objectively communicate insights and results, as well as their associated uncertainties and limitations Guidance of junior Data Analysts – supervision of task completion, support in trouble shooting challenges and contributing to performance evaluation reports Sharing of insight and best practice in community forums supporting capability development. Personal development and training in more complex data analysis skills, techniques and tooling Provision of domain data expertise (data standards, systems, metadata models, policies, business processes) in at least 1 domain area (e.g. chemistry, finance) and will be developing expertise in further domains Working with senior personnel they will contribute to Development of best practice for Data Analysis: Methods and Technology: technology evaluation, POCs Provision of training and skill development in the best practice of Data Analysis: training materials, FAQs, Playbooks and integrated operating models. 3 key specialisms include: Source Data Analysts: Support engineers build/configure source applications by defining the data requirements and modeling the appropriate data structures for given use cases. They define data quality criteria to ensure data quality integrity of the application, develop logical data models (compliant to any RMDM standards), ensure that the project deliverable aligns with the logical design and business requirements (requirements traceability). Integration Data Analyst: Support engineers build composite analytics applications by defining data requirements, data structures and data integration paths. They will identify, profile and quality assess potential source data sets, understand and comply with any data restrictions (e.g. GDPR, License, IDAP controls, etc), develop integration patterns (ETL design), support the design of target data models (compliant to any MDM standards) and document to support re-use and management of the application. Data Steward: defining and managing data governance policies, standard and operating processes; the facilitation and operation of data and information governance activities; data quality issue management; the establishment and operation of governance controls including data access, lifecycle and metadata management; risk based approach to remediation and mitigation planning. Typical People Management Responsibility (direct / indirect reports): Approximate number of people managed in total (all levels) - 2-3 Manager of a team Matrix Manager – (projects/dotted line) Education, Qualifications, Skills and Experience: Essential: Undergraduate degree in a Computer Science, Data Management or possibly discipline area (R&D, Finance, HR etc) and cross trained or equivalent number of years of experience; Proven experience in a data analyst or business role aligned to data and information management role with practical examples of performing data analysis in terms of defining requirements, gleaning critical data elements, defining data quality criteria and checkpoints; Domain data understanding: the structure, provenance and meaning of the source data crucial to the domain (eg. SAP for Finance, SDTM for Clinical). Understanding of the business processes in the generation and consumption of data Desirable: Post-graduate degree in MIS, Data Management Skills and Capabilities: Essential: The role holder will possess a blend of data requirement analysis, data quality analysis, data stewardship skills; Experience in translating requirements into fit for purpose data models, data processing designs and data profile reports Experience in the use of data modeling technologies; Experience in working in multi-skilled, multi-location data teams, working to agile principles.; Knowledge of key AZ policies and standards for data covering areas such as privacy and security.; Excellent written and verbal communication, and consultancy skills; Awareness of the end to end processes and activities in the build and support of Data solutions; Experienced in applying a risk based methodology to data and information management; Experience in the use of metadata cataloguing tools; Experience of Data Analysis enabling tool kits Desirable: Leading the work of others – task setting, supervision and coaching of more junior staff Key Relationship to reach solutions: Internal (to AZ or team): Working with peers and team leaders in the business and IT in the delivery of data capabilities; Junior data analysts in supervising delivery; Data engineering teams to deliver data structures and data provisioning processes; Data Science teams supporting ad hoc data access and provision; Key assurance teams including Risk, Privacy Information security and audit; Other data analysts across AZ to develop and extend data analysis approaches and best practices External (to AZ): Outsource partners to deliver and support data structures and data provisioning processes

Our Team Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally, Main Responsibilities The Senior Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QCd data packages including tables, figures, and listings for use in publications (i-e abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) ;The Senior Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Senior Statistical Programmer will ensure SOPs are followed and timelines and quality are met, People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs, Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry 2) Design, develop, test, implement, and document statistical programming in high-level software packages e-g SAS 3) Produce well documented data packages that include tables, listings, and figures 4) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About You Experience: Master's degree minimum 4 years/b-sc minimum 6 years of relevant experience required Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment Technical skills: Advance SAS programming skills, SDTM & ADaM (CDISC) Education: Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field, Languages: Excellent English language knowledge written and spoken Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity, Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi,! null

As a Senior Principal Statistical Programmer, you will have the opportunity to work with advanced technical solutions such as R, Shiny, and SAS, allowing you to lead asset teams and mentor junior staff effectively. In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in statistical programming. Your responsibilities will include leading the trial or asset programming team as the Lead Statistical Programmer, ensuring that asset and trial delivery aligns with established timelines and quality standards. You will perform programming activities at both trial and asset levels, including the development of SDTM and ADaM datasets and the creation of specifications. Additionally, you will develop and validate analytical outputs in accordance with the Statistical Analysis Plan and create datasets for integrated analyses like ISS or ISE. You will also be responsible for executing ad-hoc programming activities based on internal and external requests. Actively contributing to statistical programming initiatives, you will support process improvements and innovation while providing expert advice, guidance, and training to trial and asset teams, fostering the development of your colleagues' skills. Who are you: BSc or MSc (in a numerate discipline preferably in Mathematics, Statistics or Computer Science) Proven success in a Statistical Programming role within clinical development at a pharmaceutical or biotech company, or at a CRO, equivalent to a minimum of 9 years directly relevant experience. Experience in an international environment is a plus. Advanced skills in R and SAS Full familiarity of CDISC SDTM and ADaM standards (including specifications, Define.xml, and reviewers guide) and underlying concepts. Strong understanding of processes related to clinical development programs, Experience in leading e-submission processes is beneficial. Demonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomes Ability to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Key Accountabilities: Good experience as a Data Engineer with Veeva and Clinical Data Management, Experience building data pipelines for various heterogenous data sources. Must have hands-on experience in Veeva and Clinical Data Management CDMS. Identifying, designing and implementing scalable data delivery pipelines and automating manual processes Building required infrastructure for optimal data extraction, transformation and loading of data using cloud technologies like AWS, Azure etc., Develop end to end processes on the enterprise level for use by the clinical data configuration specialist to prepare data extraction and transformations of raw data quickly and efficiently from various sources at the study level Coordinate with downstream users such as statistical programmers, SDTM programming, analytics, and clinical data programmers to ensure that outputs meet requirements of end users Experience creating ELT and ETL to ingest data into data warehouse and data lakes Experience creating reusable data pipelines for heterogenous data ingestions Manage and maintain pipelines and troubleshoot data in data lake or warehouse Provide visualization and analysis of data stored in data lake Define and track KPIs and provide continuous improvement Develop and maintain, tools, libraries, and reusable templates of data pipelines and standards for study level consumption by data configuration specialist Collaborate with various vendors and cross functional teams to build and align on data transfer specification and ensure a streamlined process of data integration Provide ad-hoc analysis and visualization as needed Ensure accurate delivery of data format and data frequency with quality deliverables per specification Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business. Collaborate with system architecture team in designing and developing data pipelines as per business needs Network with key business stakeholders on refining and enhancing the integration of structured and non-structured data. Provide expertise for structured and non-structured data ingestion Develop organizational knowledge of key data sources, systems and be a valuable resource to people in the company on how to best integrate data to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including assisting with the definition, build, and validation of application program interfaces (APIs), data streams, data staging to various systems for data extraction and integration Experience in creating data integrity and data quality checks for data ingestion Coordinates with data base builders, clinical data configuration specialists and data management (DM) programmers ensuring accuracy of data integration per SOPs Provide technical support / consultancy and end-user support, work with Information Technology (IT) in troubleshooting, reporting, and resolving system issues Develop and deliver training programs to internal and external team, ensure timely communication of new and/or revised data transfer specs Continuous Improvement/Continuous Development Efficiently prepare and process large datasets for various end users for downstream consumption Understand end to end requirements for stakeholders and contribute to process and conventions for clinical data ingestion and data transfer agreements Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations Ensure compliance with own Learning Curricula, corporate and/or GxP requirements Assists with quality review of above activities performed by a vendor, as needed Assess and enable clinical data visualization software in the data flows Performs other duties as assigned within timelines Performs clinical data engineering tasks according to applicable SOPs (standard operating procedures) and processes. Experience in data engineering, building data pipelines to manage heterogenous data ingestions or similar in data integration across multiple sources including collected data. • Experience with Python/R/ RShiny, SQL, NoSQL • Cloud experience (i.e. AWS, AZURE or GCP) • Experience with GitLab, GitHub • Experience with Jenkins, GitLab • Experience deploying data pipelines in the cloud • Experience with Apache Spark (databricks) • Experience setting up and working with data warehouse, data lakes (eg: snowflake, Amazon RedShift etc.,) • Experience setting up ELT and ETL • Experience developing and maintaining data pipelines for large amounts of data efficiently • Must understand database concepts. Knowledge of XML, JSON, APIs. • Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively. • Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. • Ability to work independently, take initiative and complete tasks to deadlines. Show more Show less

Clinical Data Sciences (CDS) Key to client success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis. The Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards. While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data. CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis. Clinical Data Configuration Specialist (CDCS), Clinical Data Sciences (CDS): Key to client success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected data from all sources by setting up proper configuration of data extraction and mapping of raw data into the Common Data Model for individual studies using processes and by the Data Engineer. Work with Data Engineer to configure (Extract Transform Load)ETLs and (Extract Load and Transform)ELTs. Provide testing and documentation for data pipelines. Utilize and contribute to libraries for functions and transformation templates for reuse for study level configuration tasks. Under the guidance of Clinical Data Engineer, the Clinical Data Configuration Specialist configures and maintains the data pipelines that conform to the common data model that ensures data ingestion for all study-level data capture technologies and other related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA). Coordinates cross functionally, facilitates test data transfer, and confirms accurate DTA specification. Performs tasks to, configure, maintain, and monitor data flow integration between collected data and the clinical data repository (CDR). CDCS contributes to the successful conduct of client clinical trials and to the delivery of high quality in a timely manner, which is eventually used for statistical analysis and submitted to regulatory authorities for the approval of client products. Further, CDCS efforts enable valid secondary use of clinical trial data throughout client research groups to maximize value and achieve company objectives. Key Accountabilities: Configure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer Partner closely with internal/external stakeholders and data engineers in a collaborative manner Ensure accurate delivery of data format and data frequency with quality deliverables per specification Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business Additional Activities: Assists with quality review of above activities performed by a vendor, as needed. Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines Qualifications: Bachelor's degree plus 5 years /Masters with 3 years in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job. Experience with EDC build, Data Management, and EDC extraction configuration Knowledge of data flow between clinical data management systems, vendor devices and CDR. Knowledge of XMLS, ALS, APIs and MDR preferred. Experience with one of these languages: SQL, SAS, R, Python Understanding of SDTM Strong working knowledge of clinical trial terminology and data transfer specification expected Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively. Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Ability to work independently, take initiative and complete tasks to deadlines. Special Skills/Abilities: Strong attention to detail, and organizational skills Good time management skills Quick learner and comfortable asking questions, learning new technologies and systems Good knowledge of office software (Microsoft Office). Experience with EDC build or data extraction configuration ETL/ELT experience Understanding of AWS/Data bricks concepts Preferable but not required: Experience developing R shiny and Python apps Experience with Hadoop Experience with Agile development methods Experience with Veeva CDB Supervision: Supervision required, should be able to function collaboratively (with guidance) with all levels of employees. License/Certifications: Preferred to have SAS or R or Python certification, Physical Demands: Ability to sit and stand for long periods of time. Carrying, handling, and reaching for objects. Manual dexterity to operate office equipment i.e. computers, phones, etc. Show more Show less

Location Chennai, Tamil Nadu, India Job ID R-229637 Date posted 18/06/2025 Title - Associate Director - Data Product Manager GCL- E Typical Accountabilities: The role holder will execute the following accountabilities autonomously with limited supervisory oversight: Works with consumers / business users on the definition of the data requirements for intended data solutions. Able to translate unstructured, complex business problems into a data design and solution Profiling of data to understand provenance, quality, metadata models, ownership and compliance to internal and external regulatory standards Ad hoc wrangling of data (sourcing, extraction, profiling, integration) to support Data Science model generation and business insight Support of data engineers in the development of Source to Target pipelines (e.g. ETL design) Design & testing of the quality and performance of derivative data models in reporting and analytics solutions Processing of requests for compliant access to data Defining and managing information lifecycle management in data solutions Provision of data understanding (structure, provenance, quality) to Architects, Data Engineers and Data Scientists to support use in Analytics projects. Supports IT and business data teams in identifying and managing Critical Data Assets and Elements including Reference, Master and Metadata. Collaborates with Risk, Assurance, Privacy, Information Security and Regulatory authorities to ensure data and information controls are in place and adhered to. Clearly and objectively communicate insights and results, as well as their associated uncertainties and limitations Guidance of junior Data Analysts – supervision of task completion, support in trouble shooting challenges and contributing to performance evaluation reports Sharing of insight and best practice in community forums supporting capability development. Personal development and training in more complex data analysis skills, techniques and tooling Provision of domain data expertise (data standards, systems, metadata models, policies, business processes) in at least 1 domain area (e.g. chemistry, finance) and will be developing expertise in further domains Working with senior personnel they will contribute to Development of best practice for Data Analysis: Methods and Technology: technology evaluation, POCs Provision of training and skill development in the best practice of Data Analysis: training materials, FAQs, Playbooks and integrated operating models. 3 key specialisms include: Source Data Analysts: Support engineers build/configure source applications by defining the data requirements and modeling the appropriate data structures for given use cases. They define data quality criteria to ensure data quality integrity of the application, develop logical data models (compliant to any RMDM standards), ensure that the project deliverable aligns with the logical design and business requirements (requirements traceability). Integration Data Analyst: Support engineers build composite analytics applications by defining data requirements, data structures and data integration paths. They will identify, profile and quality assess potential source data sets, understand and comply with any data restrictions (e.g. GDPR, License, IDAP controls, etc), develop integration patterns (ETL design), support the design of target data models (compliant to any MDM standards) and document to support re-use and management of the application. Data Steward: defining and managing data governance policies, standard and operating processes; the facilitation and operation of data and information governance activities; data quality issue management; the establishment and operation of governance controls including data access, lifecycle and metadata management; risk based approach to remediation and mitigation planning. Typical People Management Responsibility (direct / indirect reports): Approximate number of people managed in total (all levels) - 2-3 Manager of a team Matrix Manager – (projects/dotted line) Education, Qualifications, Skills and Experience: Essential: Undergraduate degree in a Computer Science, Data Management or possibly discipline area (R&D, Finance, HR etc) and cross trained or equivalent number of years of experience; Proven experience in a data analyst or business role aligned to data and information management role with practical examples of performing data analysis in terms of defining requirements, gleaning critical data elements, defining data quality criteria and checkpoints; Domain data understanding: the structure, provenance and meaning of the source data crucial to the domain (eg. SAP for Finance, SDTM for Clinical). Understanding of the business processes in the generation and consumption of data Desirable: Post-graduate degree in MIS, Data Management Skills and Capabilities: Essential: The role holder will possess a blend of data requirement analysis, data quality analysis, data stewardship skills; Experience in translating requirements into fit for purpose data models, data processing designs and data profile reports Experience in the use of data modeling technologies; Experience in working in multi-skilled, multi-location data teams, working to agile principles.; Knowledge of key AZ policies and standards for data covering areas such as privacy and security.; Excellent written and verbal communication, and consultancy skills; Awareness of the end to end processes and activities in the build and support of Data solutions; Experienced in applying a risk based methodology to data and information management; Experience in the use of metadata cataloguing tools; Experience of Data Analysis enabling tool kits Desirable: Leading the work of others – task setting, supervision and coaching of more junior staff Key Relationship to reach solutions: Internal (to AZ or team): Working with peers and team leaders in the business and IT in the delivery of data capabilities; Junior data analysts in supervising delivery; Data engineering teams to deliver data structures and data provisioning processes; Data Science teams supporting ad hoc data access and provision; Key assurance teams including Risk, Privacy Information security and audit; Other data analysts across AZ to develop and extend data analysis approaches and best practices External (to AZ): Outsource partners to deliver and support data structures and data provisioning processes Date Posted 19-Jun-2025 Closing Date 23-Jun-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. ]]>

Role & responsibilities 1) Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials 2) Experience creating and working with Utility Macros 3) Experience creating specification 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs 12) Experience in Ephicacy and safety tables. We have opening for other roles to.... SAS Macros, Bio statics Interested candidates can share thier resumes at - shubhanshi.agarwal@mounttalent.com Whatsapp - 7302239534

SAS MACROS Pan India One of the leading Lifescience company in India mail at manjeet.kaur@mounttalent.com Whatsapp at 8384077438 Experience Required : 7 to 10 Years of experience 1)Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required 6) Develop, Debug Utility macros for reusability and efficiency Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs

Job Description In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC and other analysis data sets Assists Data Management with SAS programming needs Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team Develops and validates general SAS macros What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. Responsibilities How you will contribute: Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Submissions experience utilizing define.xml and other submission documents. Experience supporting immunology, respiratory or oncology studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. Show more Show less

Novo Nordisk Global Business Services ( GBS) India Department - Global Data & Artificial lntelligence Are you passionate about building scalable data pipelines and optimising data workflowsDo you want to work at the forefront of data engineering, collaborating with cross-functional teams to drive innovationIf so, we are looking for a talented Data Engineer to join our Global Data & AI team at Novo Nordisk. Read on and apply today for a life-changing career! The Position As a Senior Data Engineer, you will play a key role in designing, developing, and main-taining data pipelines and integration solutions to support analytics, Artificial Intelligence workflows, and business intelligence. It includes: Design, implement, and maintain scalable data pipelines and integration solutions aligned with the overall data architecture and strategy. Implement data transformation workflows using modern ETL/ELT approaches while establishing best practices for data engineering, including testing methodologies and documentation. Optimize data workflows by harmonizing and securely transferring data across systems, while collaborating with stakeholders to deliver high-performance solutions for analytics and Artificial Intelligence. Monitoring and maintaining data systems to ensure their reliability. Support data governance by ensuring data quality and consistency, while contributing to architectural decisions shaping the data platform's future. Mentoring junior engineers and fostering a culture of engineering excellence. Qualifications Bachelor’s or master’s degree in computer science, Software Development, Engineering. Possess over 10 years of overall professional experience, including more than 4 years of specialized expertise in data engineering. Experience in developing production-grade data pipelines using Python, Data-bricks and Azure cloud, with a strong foundation in software engineering principles. Experience in the clinical data domain, with knowledge of standards such as CDISC SDTM and ADaM (Good to have). Experience working in a regulated industry (Good to have). About the department You will be part of the Global Data & AI team. Our department is globally distributed and has for mission to harness the power of Data and Artificial Intelligence, integrating it seamlessly into the fabric of Novo Nordisk's operations. We serve as the vital link, weaving together the realms of Data and Artificial Intelligence throughout the whole organi-zation, empowering Novo Nordisk to realize its strategic ambitions through our pivotal initiatives. The atmosphere is fast-paced and dynamic, with a strong focus on collaboration and innovation. We work closely with various business domains to create actionable insights and drive commercial excellence.

Designation : Senior Product Manager Experience : 7+ years with at least 3+ years in a Senior role Location: Remote (India) Education Bachelor’s degree, preferably in Computer Science, Electrical Engineering, Physics, Math or any other related discipline; Master’s degree, a plus. Essential skills Exceptional leadership and communication skills, capable of influencing senior executives and driving cross-team alignment. Desired skills Certified Scrum Master (CSM) or Certified Scrum Product Owner (CSPO) with a deep understanding of Agile methodologies. Experience working in regulated environments, including knowledgeof 21 CFR Part 11 compliance. Certifications, if any CSM/CSPO Summary Resource with leadership skills, influencing capability and experience working in regulated environments. Roles & Responsibilities Product Strategy & Vision: Define and evolve the product vision and roadmap for clinical trial data science solutions, ensuring alignment with corporate goals, market trends, and customer feedback. Industry Expertise: Maintain a strong understanding of the biopharma landscape, regulatory requirements (such as FDA guidelines), clinical trial workflows, and competitive offerings to influence product decisions and create differentiation. Stakeholder Management: Lead collaboration across multiple stakeholders, including cross-functional teams (engineering, services, support) and senior leadership, ensuring alignment on product priorities and delivery timelines. Agile Leadership: Lead Agile product development cycles as a senior product owner, overseeing backlog prioritization, sprint planning, and acceptance criteria in a CI/CD environment. Market & Competitor Analysis: Conduct continuous competitor and customer request analysis to identify opportunities and gaps in product offerings. Specify new features that address unmet customer needs or emerging trends in clinical trial data science. Customer-Centric Development: Engage with customers to gather feedback, validate feature development, and ensure the product addresses pain points in data management, workflow, and compliance. Risk Management: Analyze customer adoption and operational risks for upcoming releases, proactively identifying potential mitigation steps. Essential Experience 5+ years in software product management, preferably in a SaaS or cloud-based environment. 3+ years of experience managing products for the biopharma or life sciences industry, particularly in clinical trial data science. Proven ability to lead cross-functional teams and manage complex product lifecycles in a fast paced, Agile environment. Strong knowledge of clinical trial processes, data standards (CDISC, SDTM), and regulatory submission requirements. Expertise in data platforms and analytics tools used in clinical trials (e.g., SAS, Python, R). Desired Experience Certified Scrum Master (CSM) or Certified Scrum Product Owner (CSPO) with a deep understanding of Agile methodologies. Experience working in regulated environments, including knowledge of 21 CFR Part 11 compliance. Show more Show less

OVERVIEW The Data Engineer will work closely with clients and the eCS Biometrics team to optimize the elluminate platform for end-to-end solutions to aggregate, transform, access and report on clinical data throughout the life cycle of a clinical trial. This includes study design in elluminate, collaboration on specifications, and configuration of the various modules to including Data Central, Clinical Data Analytics and Trial Operational Analytics, Risk-Based Quality Management (RBQM), Statistical Computing Environment (SCE) and Operational Insights. The Data Engineer will be involved in standard ETL activities as well as programming custom listings, visualizations and analytics tools using Mapper and Qlik. The position involves a high level of quality control as well as adherence to standard operation procedures and work instructions and a constant drive towards automation and process improvement. KEY TASKS & RESPONSIBILITIES Design, develop, test, and deploy highly efficient code for supporting SDTM, Custom reports and Visualizations using tools like MS SQL, elluminate® Mapper and Qlik Configure ETL processes to support of the aggregation and standardization of clinical data from various sources including EDC systems, SAS and central laboratory vendors Work with Analytics developers, other team members and clients to review the business requirements and translate them into database objects and visualizations Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned Provide diagnostic support and fix defects as needed Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures Other duties as assigned CANDIDATE’S PROFILE Education & Experience 3+ years of professional experience preferred Bachelor's degree or equivalent experience preferred Experience with database/warehouse architecture, design and development preferred Knowledge of various data platforms and warehouses including SQL Server, DB2, Teradata, AWS, Azure, Snowflake, etc. Understanding of Cloud / Hybrid data architecture concepts is a plus Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards Experience in Pharmaceutical/Biotechnology/Life Science industry is a plus Professional Skills Critical thinking, problem solving and strong initiative Communication and task management skills while working with technical and non-technical teams (both internal to eCS and clients) Must be team oriented with strong collaboration, prioritization, and adaptability skills Excellent knowledge of English; verbal and written communication skills with ability to interact with users and clients providing solutions Excited to learn new tools and product modules and adapt to changing technology and requirements Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred Technical Skills Proficient in SQL, T-SQL, PL/SQL programing Experience in Microsoft Office Applications, specifically MS Project and MS Excel Familiarity with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle Familiarity with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related Familiarity with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related

Job Title: Clinical Data Management Developer Experience: 4+ Years Location: Remote Work Hours: 9:00 AM – 6:00 PM IST Contract Type: Short-Term Contract Position Overview We are actively seeking a talented and experienced Clinical Data Management Developer with a strong foundation in Python programming and Electronic Data Capture ( EDC ) systems to support critical clinical research and data operations. This role is ideal for professionals who are passionate about improving the quality and integrity of clinical trial data through innovative technology and clean, reliable code. The successful candidate will have practical experience in tools such as MedDataRave and Inform , and demonstrate a deep understanding of clinical trial data standards like SDTM and CDISC . Your work will directly support regulatory submissions, data transformation, and analytics across a wide variety of clinical studies. Key Responsibilities Develop and maintain automated data pipelines and data transformation scripts using Python in a clinical research context. Integrate data across multiple EDC platforms such as MedDataRave and Inform . Ensure data quality, consistency, and compliance through the application of SDTM and CDISC standards. Perform data cleaning , validation, and mapping in line with regulatory and clinical protocols. Collaborate with biostatisticians, data managers, and clinical operations teams to support data lifecycle activities. Support the development of SaaS-based tools and platforms for clinical data management and reporting. Troubleshoot and resolve data issues and discrepancies with a problem-solving mindset. Contribute to regulatory submission readiness , audit support, and documentation. Participate in design and optimization of CRFs and clinical workflows. Show more Show less