185 Sdtm Jobs

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 . Duties/Responsibilities Lead/actively participate in departmental and/or cross-functional initiatives geared towards updated technological solutions, process improvements, standards and governance updates etc. and regularly disseminate information to teams and stakeholders. Drive forward a lean SDTM implementation group capable of delivering quality SDTM data early in a clinical trial with innovative transformation solutions. Keep abreast of CDISC industry standards and participate in industry wide technical discussions via conferences and webinars. Represent SDTM programming during internal audits as needed. Managerial Responsibilities: Develop job descriptions and career paths for programmers and effectively forecast resource needs, recruit, manage, develop, evaluate, reward, motivate and retain 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 direct 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 Head of Clinical Data Strategy, Systems, Reporting and Analytics regarding promotions, performance concerns, and retention risks. Build inter-departmental relationships and resolve issues as needed. Qualifications Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred. Minimum of 10 years clinical/statistical programming experience within pharmaceutical clinical development. Minimum 5 years of experience in managing technical professionals in a regulated environment. 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.

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 . Duties/Responsibilities Lead/actively participate in departmental and/or cross-functional initiatives geared towards updated technological solutions, process improvements, standards and governance updates etc. and regularly disseminate information to teams and stakeholders. Drive forward a lean SDTM implementation group capable of delivering quality SDTM data early in a clinical trial with innovative transformation solutions. Keep abreast of CDISC industry standards and participate in industry wide technical discussions via conferences and webinars. Represent SDTM programming during internal audits as needed. Managerial Responsibilities Develop job descriptions and career paths for programmers and effectively forecast resource needs, recruit, manage, develop, evaluate, reward, motivate and retain 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 direct 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 Head of Clinical Data Strategy, Systems, Reporting and Analytics regarding promotions, performance concerns, and retention risks. Build inter-departmental relationships and resolve issues as needed. Qualifications Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred. Minimum of 10 years clinical/statistical programming experience within pharmaceutical clinical development. Minimum 5 years of experience in managing technical professionals in a regulated environment. 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.

Bulk Hiring - Clinical SAS Programmer Mode: WFH-Permanent Salary:No Bar Skills: Statistical Programming /SAS Programming, SDTM, ADaM, TLF /TLG, Efficacy. Qualification: PG-degree in statistics, computing, life science-related field B.E/B.Tech.

Position Summary: The Clinical Data Manager II is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements. The Clinical Data Manager II is able to assist and lead data management team and provide support to Lead Clinical Data Manager, develop project documentation, project plans, EDC system setup, data review and validation processes. Role & responsibilities Implements, monitors and supervises data management activities within assigned clinical trials, i.e., is responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans and Data Management Plans Provides the study status updates with respect to data, using standard reports (CPT, data entry, queries, SDV, safety reconciliation etc.) and communicates efficiently the status to the team Creates and executes data quality checks throughout the study conduct Day to day responsibilities (under the guidance of senior personnel) may include but are not limited to: data review, open/close queries in the eCRF, medical coding, central lab data reconciliation, PK data reconciliation, ad-hoc data reports creation, User Acceptance Testing (UAT) of internal and external electronic Data Capture systems Provides support to the resolution of issues and inputs ideas to help resolve issues and contribute to continuous improvement Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection Key competencies: Excellent knowledge of CDISC/SDTM/ADAM specifications Excellent IT skills and MS Office command Ability and willingness to operate independently Ability to communicate effectively both verbally and in writing Ability to manage multiple and varied tasks and prioritize workload with attention to detail Demonstrate quality driven mindset while performing any of the assigned tasks Excellent knowledge of ICH/GCP, 21 CFR Part 11, guidelines and regulations, particularly those relevant to clinical data management Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice Professional Experience Requirements: Required: 8 Years experience as Clinical Data Manager Phase I -III Studies Desirable: Experience working with Medidata Rave Education Requirements: Required: BSc in Statistics, Biostatistics, Mathematics, Data Science or other applied sciences relevant field, life science, pharmacy or related subject or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) Desirable: MSc in one of the above fields

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS reports for DM function.( E.g., missing pages report, reconciliation report, patient profiles etc). Key requirements: 1) SAS Programmers with a minimum of 10 years of experience in clinical SAS programming. Python is good to have skillset. 2) Min 5 years of SAS experience with good understanding of DM and clinical stake holder requirements. Additional details: Responsibilities include (but not limited to) design, development, implementation, and validation of programs created in SAS dashboard applications, to process, analyze and report clinical trial data for review by clinical study teams. Works within established frameworks and ensures high quality is built into own deliverables. Works independently for well-defined scope of work Under guidance, creates catalogue of reports to aid data cleaning activities with moderate scope and medium complexity, but not limited to: Automate manual checks. Automate reconciliation and program edit checks for TPV data to ensure quality. Create tools and repository to minimize data errors at source for collection of lab reference ranges. Program reports to identify missing pages and also detect errors at Subject level. Create reports to measure metrics that can help assess data cleaning status. Create visualizations and dashboards to identify discrepancies in EDC and TPV data. Maintain created catalogue of reports and perform updates based on ongoing changes to requirements. Provide support as required to ensure availability and performance of developed reports and dashboards for both external and internal users Responsible for completion of documentation associated with programming tasks (e.g. peer review, report specifications etc.) in compliance with applicable SOPs Proactively keeps the lead programmers updated on progress of deliveries. Contribute to implementation of cross-functional projects that are part of clinical programming roadmap.

Job Description: The ideal candidate will have over 4 years of experience working within Data Warehouse platforms in a regulated industry, specifically within a clinical trial environment (IDAR). This role demands a deep understanding of data visualisation tools, scripting languages, and SDTM data structures, along with the ability to work independently on complex assignments. Responsibilities: The service holder will be responsible to function in a continuous improvement framework with respect to systems deployment, life cycle management and enhancements supported user groups. The Analyst will contribute to initiatives to yield faster and more effective report development, efficient change management services for analytics platforms. The analyst will have technical expertise with clinical data and report building, and experience gained through working with diverse and complex business processes and associated system infrastructures. The Analyst is required to work in a matrix environment across functions and departments What Required: More than 4 years experience as a Business Analyst, working within Data Warehouse platforms in a regulated industry within a clinical trial environment (IDAR) In depth knowledge of Tibco Spotfire, Power BI or Tableu or other equivalent visualization development tool Hands on experience of Python, R, SAS and similar scripting languages [Must] Hands-on of SDTM data structure (for IDAR) [Must] Knowledge to gather requirements and writing user requirement documentation Ability to work independently on assignments of moderate to high complexity without support. Interested candidates may share resume with Puja.k@maxisclinical.com

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Update BOT query sheet as and when requested by the TDM.Ensure completeness and validity of clinical as well as external data.Generate missing page report and track missing pages, as required.Track discrepancy and query status of assigned studies/Investigative sites as applicable.Review data from first data received to last data received and for selected tasks supporting the interim analysis/final database lock by operating in a continuous cleaning process.Perform DD pass activities as needed.Perform review for SDTM Data sets (SITS), P21 and other applicable reports.Share the weekly study metrics with TDM.Act as back up for TDM and lead study related meetings/document MOM and perform task allocation applicable for Data Manager, as needed.Upload standard reports/manual listings (DQPM listings) to central client location as guided by Lead Data Manager or client counterparts.Maintain an issue log to track and resolve discrepancies. Ensure issue clarification/follow-up until closure per the Issue Escalation Process/guidelines, as applicable.Interact with the TDM/Lead regarding data quality issues and assist them in tracking, monitoring the progress of data review activities.Accountable for high quality and on time delivery for assigned deliverables.Achieve the applicable SLA/KPI metrics. Qualification Bachelor of Pharmacy

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) Essential: Education, Qualifications, Skills and Experience: 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 Essential: Skills and Capabilities: 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.

Job Title: Senior Business Analyst ( Saama Product ) Career Level - D1 Introduction to role AstraZeneca is currently looking for an IT Business Analyst/Business Systems Analyst to join our R&D IT Solution Delivery Team to manage and maintain our SaaMa product, which is GxP compliant and part of Clinical Development Platforms. This product is used across late science teams in all therapeutic areas. As a member of our BizDevOps team, you will work cross-functionally with other team members such as the Product Lead, DevOps Lead, and technical engineers. Accountabilities Collaborate with Business stakeholders - hold requirements elicitation sessions as well as backlog refinement sessions Document business requirements for the technical team (user stories with acceptance criteria) Work with business and technical staff to prioritize requirements that need to be delivered for each sprint Collaborate with the technical team to understand operational challenges Assist Release Manager and Product BA in roadmap and release planning Assist in coordination and supervision of the release process in terms of compliance artifacts - gather stories approvals, support Business stakeholders with BCR, BCCF, etc. Document BA-related processes and information in Confluence (ways of working, Jira-related information, etc.) Assist system owners in conducting help clinics and feedback sessions for end users to improve the overall quality of the platform Assist in the preparation of business cases to aid in decisions on system implementation Assist with system testing activities by creating/reviewing test cases and providing requirement clarifications to the testing team Contribute to regression testing activities by providing feedback on the test suite to ensure necessary functional requirements are covered and enhanced in every release Execute regression test cases independently or in association with the testing team Assist in creating or create UAT test cases that cover essential business scenarios/use cases Train testers from the business side on the functional aspects of the application Clarify any functional queries that may arise during testing activities Follow up with UAT testers, QM’s, and all relevant stakeholders to get sign-off on UAT Proactively drive identification of opportunities to be leveraged in solutions delivered Essential Skills/Experience Experience in Monitoring and Visualization Analytics Applications Experience in clinical data management, clinical data analytics, and visualization, clinical data programming experience Knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics, and reporting Excellent understanding of common industry-standard business practices as related to clinical trials (study setup, clinical operations, data management, and reporting) Excellent knowledge of software development, testing processes, and methodologies and undeniable passion for business and system analysis Excellent written, verbal communication, and relationship management skills Able to work independently with minimum supervision Scrum Master Certification, Knowledge of Agile/Scrum methodology Experience working with JIRA, Confluence Experience of change management process in GxP validated SaaS environment Desirable Skills/Experience Self-motivation and an ability to contribute to rapidly evolving programs Working knowledge of CDASH, SDTM, ADaM, and CDISC controlled Terminology in the context of clinical data Experience in EDC (such as RAVE, Inform, Veeva) and Data Management Experience with and knowledge of tools that can help make software delivery and testing more effective Worked in a global organization where stakeholders and project team members are geographically dispersed Familiar with project management and business analysis software Knowledge and experience in Integration technologies like Mulesoft (or) Snap logic is a plus When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients by transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions while being supported all the way. Ready to make a difference? Apply now! Date Posted 03-Jun-2025 Closing Date 29-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.

Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in FSP.

6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis

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 . Duties/Responsibilities: Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for BMS studies Serve as Study SDTM Programming lead for all regulatory submissions. Expertise in BMS SDTM automation tools, macros and using them for SDTM programming. Identify any inefficiencies and work with experts in up-versioning/enhancing existing tools and macros. Thorough knowledge of CDISC standards including CDASH/SDTM/ADaM and keep abreast of latest updates in the industry. Design/implement the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements. Work with standards team to design mapping algorithms for new items. Provide input to the design of the clinical trial database from an SDTM perspective. Annotate CRFs and Review annotated CRFs in accordance with BMS guidelines and appropriate metadata to reflect tabulation datasets. Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools to ensure regulatory compliance. Provide common language for repeated unresolvable validation issues across projects within a compound for inclusion in SDRG. Collaborate with stakeholders and Study team members to manage study timelines and resolve issues. Represent SDTM Programming function in Study team meetings as well as cross-functional working groups. Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies. Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables. Participate in study/project team meetings as a core member and provide technical expertise/support. Qualifications: BA/BS in a relevant scientific discipline with more than 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM. Significant knowledge of SAS software and general computing as relates to clinical drug development. Knowledge of the drug development process, clinical trial methodology, CDISC Standards and familiarity with global regulatory requirements Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Ability to be flexible and adapt quickly to the changing needs of the organization Ability to organize multiple work assignments and establish priorities 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.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Job Title: Manager, Clinical Systems Location : Bangalore Foster a culture of continuous improvement by streamlining processes and adding value across the business Ensure high-quality work compliant with GCP, ICH guidelines, and all applicable regulations Oversee administrative activities such as time-sheets, training (iLearn and sponsor-specific), and leave management for the team Manage and support local and global Clinical Systems teams to meet project timelines and budgets Liaise with project/study teams, ensuring timely communication and escalation of issues Drive effective resource allocation and workload balancing with Team Leaders and Study Leads Forecast resource needs and support recruitment efforts Mentor and guide team members by providing technical and leadership support Represent Clinical systems in audits, sponsor meetings, and cross-functional presentations Identify gaps in processes and suggest improvements proactively Conduct performance appraisals and define development plans for team members Bachelor’s or Master’s degree in Life Sciences or a related discipline Minimum of 13+ years of experience in Clinical Systems,Analytics Preferred hands-on experience with one or more Clinical Systems such as Rave, Central designer Veeva and Elluminate, exposure to data visualization, Python, and data analytics tools is also highly desirable. Knowledge on SDTM and SAS would be an advantage. Prior experience in managing or colloborating with cross functional teams ( Internal and Client facing) and ability to operate under matrix operations structure. Desire for continous learining and driving innovative solutions. Strong understanding of regulatory requirements (GCP, ICH, FDA, etc.) Representation and contribution in Industy conferences and engagments is preferred. 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 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.

Statistical Programmer – R Programmer (Remote opportunity) Location: Remote (India) Experience: 6 to 10 years About the Role: We are hiring a Statistical Programmer with strong R programming experience to join our growing team. This is a remote opportunity tailored for professionals passionate about clinical data analysis and programming, with expertise in CDISC standards. Key Responsibilities: Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in an FSP environment Debug and utilize standard macros efficiently Preferred involvement in integrated summaries (ISS/ISE) Must-Have Skills: 6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis Study-level handling experience (for senior-level profiles) Preferred Skills: Experience with CRT package (Trial Data Domain) Prior involvement in ISS and ISE Experience in an FSP environment Familiarity with standard macro debugging and utilization Why Join Us? 100% Remote Role Be part of a specialized Data Science and Clinical Programming team Opportunity to work on impactful global healthcare projects

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

Hiring Alert: SDTM Programmer with 6+ years of experience! Prefer early joiners for a remote opportunity in India. Salary Expectation - NO Bar Work from home - India SDTM Mapping

External Job Description Job title: Senior Data Management Programmer Location: Hyderabad, India About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Data Management Programmer within our Hyderabad Hub, you’ll be responsible for developing program for data validation, data review and protocol deviation deliverables for assigned projects, providing timely support to Study Team(s) on data management programming or data visualization analytics according to project data cleaning strategies through project milestones from study start-up to database lock. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities: Developing listings, summary tables, figures and/or advanced analytics for data validation, data review, medical review, AE dedicated review and SAE reconciliation Distributing and/or deploying data review and data validation solutions which are checking all collected data including external data (i.e., cross-panel checks and internal/external data reconciliation) Developing automatic protocol deviations identification solutions Liaising with standard Data Reporting Analyst (DRA) to continuously maintain and optimize the existing standard reporting tools, programs and report library. Developing efficient Power BI, Spotfire, R/Shiny & SAS standard packages facilitating the programming of study solutions Managing the technical writing at CTT level (i.e., user guides, detailed specifications, best practices, programming conventions, etc.) Analysing new requirements from customer and propose technical solution strategies. About you Experience : At least 4 years’ SAS programming experience, or have other equivalent programming language experience such as R/R shiny, Python, or have equivalent data visualization tools experience such as Spotfire, Power BI, Tableau In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred. Soft and technical skills : Advanced project management skill Advanced collaboration and communication skill Outstanding capability of independent thinking and delivery of accurate outcomes. Meeting management skill such as organize meeting and discussion Crystal clear logical thinking. Intercultural skills with ability to work effectively in a multi-cultural context. Advanced expertise in programming language such as SAS, R, Python. Advanced expertise in database structure and data flow Strong knowledge of industry standards and practices (e.g. CDISC especially CDASH and SDTM). Knowledge of data visualization tools such as Spotfire, Power BI, Tableau. Experience in implementing and fine-tuning AI/ML model Strong knowledge of current regulatory guidelines, and GCP practices regarding Data Management. Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Education : Bachelor or Master of Science degree or above, preferably in a life science or mathematics-related area (e.g., Pharmaceutical, medical, or mathematics, computer science or similar technical fields). Languages : Strong English skills (verbal and written), ability to exchange fluently in a global environment. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Join an international innovative biopharma company. Lead data management programming activities and serve as an expert working on several therapeutic areas. Participate in the evolution of Clinical Data Management and deployment of innovations “As a senior data management programmer in our India Hub, you’ll get the opportunity to lead data management programming for global studies in different therapeutic areas and act as the data management programming expert to develop your career in the global organization. Join the Best, Be the Best!”

Job Job TitleKey Account Executive - E-Commerce Company NameTitan Job TypeRegular/ Job CategoryOther DepartmentE-Commerce LocationBengaluru, Karnataka, India Titan, a leading retail company in India, is seeking a highly motivated and experienced Key Account Executive to join our E-Commerce team in Bengaluru. As a Key Account Executive, you will be responsible for managing and growing our key accounts in the E-Commerce sector. Growth Primary/ Retail Sales 1) Meeting the monthly primary/ retail sales target of designated platforms. 2) Ensuring growth in sales Value YoY by planning necessary marketing activities and understanding the category trend. 3) Preparing the monthly Inventory range plan in association with merchandiser based on ROS & New Product launch 4) Timely Co-ordination with Supply chain, CFAs and Platforms for entire order fulfilment lifecycle. 5) 95%+ of range plan is live at any time. Value Creation Debtors, Payouts & Compliance 1. No over dues for the review period -Sending Reminders to partner on overdue/outstanding. Collecting sales data for credit note working. 2. All payouts should be in the budgeted limits 3. Timely Communication to internal stakeholder & associates Customer/ Stakeholder Satisfaction Partner Management 1) Healthy working relationship with internal and external stakeholders 2) Periodic business review meet with all partners (Internal & External) 3) Listing of the new products with correct information on the platforms 4) Resolving partners disputes in coordination with internal stake holders. 5) Uploading the schemes/ discounts as per the planned schemes. Innovation New Process and Initiative 100% listing of active line on the platforms Continuous replenishment for Top Sellers for partner with a Fill rate of at least 75% 10% contribution of NP on a overall target. Work Experience Education QualificationsGraduation ExperienceMinimum 1 year experience in a consumer goods company (Fashion, Electronics, FMCG) or retailers ( Flipkart/ Myntra/Amazon/ Shoppers Stop/ Lifestyle/ DMart ) \u2013 working in a sales / operations role Skills: MS Excel and data management Written & Spoken skills stake holder management Communication skills.

Skills: SDTM, ADAM, TLF & Immunology Position Summary The Manager of Biostatistics is a member of cross-functional study/project teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. These individuals develop collaborative relationships and work effectively with the Biostatistics Lead, and other cross functional team members. Key Responsibilities Contributes to designing clinical trials to address study hypotheses and objectives. Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications, and other study level specification documents under supervision. Performs and/or validates preplanned or ad hoc statistical analyses with guidance as needed. Presents & interprets results to GBDS and/or cross-functional team members. Translates scientific questions into statistical terms and statistical concepts into layman terms. Compliant with processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable. Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results. Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Qualifications & Experience MS in statistics, or biostatistics or related scientific field with 1-2 years’ experience in clinical trials, drug development, pharmaceutical industry or healthcare experience (including internship) preferred. Proficiency in scientific computing/programming (SAS, R or Python) and implementation of statistical analysis, data manipulation, graphing & simulation. Good interpersonal, communication, writing and organizational skills Ability to: learn regulatory requirements & clinical trial design, data analysis and interpretation, work successfully within cross-functional teams, organize multiple work assignments and establish priorities

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.sdtm programmerProgram mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for sdtm programmersdtm programmer Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation,BE,BTech

Job Overview Provide advanced technical expertise to develop and maintain programs to meet internal and external clients needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. Essential Functions • Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. • Program the integration of databases from multiple studies or sources. • Develop programming documentation including plans and specifications, as appropriate. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department. • Perform and plan the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of statistical team lead for single studies, under supervision. • Understand the Scope of Work, estimate the work completed, and manage Out of Scope for single studies. May manage budget and resource requirements and provide revenue and resource forecasts for single studies. May be required to understand budget and quote assumptions. • Provide training and guidance to lower level and new staff. Qualifications • Master's Degree Computer science or related field and 1 year relevant experience Req Or • Bachelor's Degree Computer science or related field and 2 years relevant experience Req • Equivalent combination of education, training and experience Req • Knowledge of statistics, programming and/or clinical drug development process • Working knowledge of computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, leadership and communication skills • Ability to effectively handle multiple tasks and projects • Excellent accuracy and attention to detail • Ability to establish and maintain effective working relationships with coworkers, managers and clients

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. ]]>