186 Sdtm Jobs - Page 3

Function Data Analytics & Computational Sciences Sub function Clinical Data Management Category Experienced Analyst, Clinical Data Management (P5) Location Mumbai / Hyderabad / Bangalore / India Date posted Jun 17 2025 Requisition number R-009777 Work pattern Hybrid Work Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India Job Description: Integrated Data Analytics and Reporting (IDAR) Analyst II External Data Acquisition Expert* (*Title may vary based on Region or Country requirements) Position Summary: The Analyst II External Data Acquisition Expert is an experienced individual contributor with an in-depth understanding of data acquisition capabilities, practices, methods, processes, and technologies. In this role the Analyst II Data Acquisition Expert contributes to delivery of the J&J R&D portfolio through accountability and/or execution of the set-up and management of External Data Stream systems at the trial level. This position will be able to perform work activities with minimal supervision, take a lead role, and may coach/mentor others. This position reports to Data Acquisition Functional Leadership and represents Data Management in cross functional discussions, with the ability to influence key stakeholders and contribute to strategic discussions and decisions. This position may also participate in continuous improvement initiatives and industry work groups. This position develops strong and productive working relationships with key stakeholders within IDAR and Global Development, in addition to broader partners, external suppliers and/or industry groups. Principal Responsibilities: Planning, execution, and completion of all data acquisition activities and deliverables within assigned scope, ensuring quality, compliance standards, consistency, and efficiency. Ensure timely and effective maintenance of functional planning systems. Independently and effectively manage issue escalations, adopting appropriate escalation pathways. Anticipation, early detection, prevention and management of risks and issues impacting deliverables and activities. Contribute to the development and maintenance of departmental policies, procedures, training, and standards. Contribute to the development of functional vendor contracts and oversee of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates. Contribute to the enhancement of functional, technical and/or scientific capabilities within data management. Influence the external industry and/or regulatory environment through active engagement in industry forums and working groups. Support data acquisition related aspects of regulatory agency inspections and internal audits. Ensure real time inspection readiness for all data acquisition deliverables. This position may be specialized into the following roles based on business needs: Data Acquisition Expert External Data Data Acquisition Expert External Data role-specific responsibilities: Accountable for the setup & maintenance of External Data Streams within assigned trial(s) according to best practices and defined guidelines. External Data Streams include but not limited to ePRO, eSource, EHR, Real World data and traditional and novel clinical data streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS). Activities/deliverables include but not limited to development of trial specific data transfer agreements & specifications, verification of data transfers, and setup of automated data ingestion into the clinical data repository. Principal Relationships: Reports into people manager position within functional area (e.g., Data Acquisition Leader). Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators. External contacts include but not limited to: External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Required Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD). Approx. 5+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. Proven knowledge of data management practices (including tools and processes). Proven knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., CDASH, SDTM). Intermediate project and risk management skills with an established track record delivering successful outcomes. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Strong communication, leadership, influencing and decision-making skills. Strong written and verbal communications skills (in English) Demonstrated technical expertise developing and maintaining External Data Streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS) and associated components (e.g., Data Transfer Agreements & Specifications, transfer file verification, data ingestion set-up). Preferred Innovative thinking to allow for optimal design and execution of clinical development strategies. Ability to contribute to the development and implementation of a business change/innovative way of working. Experience working with data from EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms. Other: Approx. <10% travel (domestic or international) may be required.

Premier Research is looking for a Principal Biostatistical Programmer to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. This role will be specifically working in our end-to-end team therefore SDTM, ADaM and TLF experience is required. 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. Show more Show less

Location Bengaluru, Karnataka, India Job ID R-228130 Date posted 16/06/2025 Job Title: Principal Programmer - Data Science Systems Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Career Level: E – Individual Contributor position. Introduction to role: Are you ready to make a difference in the world of data science? As a Principal Programmer in Data Science Systems, you'll be at the forefront of developing ground breaking applications and methodologies within the Quantitative Sciences organization. Your strong technical, organizational, and project management skills will guide internal and external collaborators in implementing software tools and technologies that redefine clinical study development and execution. Collaborate with leaders in Programming, Biostatistics, Epidemiology, and Medical Writing to identify technology needs and streamline practices. Dive into the world of data science technologies to improve clinical analyses and operations. Accountabilities: Develop, maintain, implement, and manage applications using data science software within the QS organization. Coordinate project direction for internal and external projects in tool development and deployment. Lead life cycles of data science services including versioning, training, and documentation. Review and supervise change requests for data science applications. Find opportunities for new data science technologies to improve QS operations. Research alternative solutions to current problems with recommendations for efficient solutions. Implement standard methodologies in software development to improve quality and efficiency. Develop Standard Operating Procedures for regulatory deliverables using data science technologies. Serve as a liaison with Alexion IT for tool development using data science technologies. Represent QS Statistical Programming in cross-functional projects for innovative solutions. Act as a subject matter authority on data science technologies during audits. Provide training to DOQS and contracted staff for applications developed with data science technologies. Lead department data science environment for clinical study data analysis. Coordinate aspects of applications developed with data science technologies including licenses and user accounts. Serve as a statistical lead programmer contributing to project programming efforts. Develop and validate programming specifications for analysis datasets using Alexion standards. Independently develop programs generating analysis datasets based on specifications. Develop programming specifications for protocol-specific safety and efficacy tables. Independently develop programs generating safety and efficacy tables using Alexion specifications. Represent Alexion at conferences to present data science technology trends. Crucial Skills/Experience: BS/MS/MA in Statistics, Biostatistics, Computer Science, Data Science, Mathematics or related area. Advanced degree or equivalent experience with strong analytical skills is preferred. 6+ years’ data science or statistical programming experience in the pharmaceutical, biotech or CRO Industry. Some proven experience and solid understanding of data science technologies such as R, Python, C++, C#, Java or AI/machine learning. 2+ years project management experience in the biotech or pharmaceutical industry is required. Work experience and validated skills in the use of R or SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs is required. Confirmed abilities to lead and handle cross-functional projects from concept to completion. Proficiency in the roles and responsibilities of all related subject areas within the QS department, with a focus on Biostatistics, Clinical Data Management, Epidemiology, and Medical Writing. Strong verbal and written communication skills with ability to clearly and effectively present information. Strong knowledge and understanding of software development with familiarity of a general programming language (i.e. C++, Java, Python, etc.), version control (Git), CI/CD platforms, open-source and private APIs, and various SDE tools. Experience with CDISC SDTM and ADaM models and clinical analysis reporting is preferred. Knowledge of clinical database design specifically electronic data capture and management, and the implementation of external data sources is preferred. Advanced experience with: Constructing technical programming specifications. Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Crafting all files necessary to support an electronic submission in the eCTD format. 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's Alexion division, we champion diversity and foster an energizing culture where new ideas thrive. Our commitment to inclusion ensures that life-changing innovations can come from anywhere. We celebrate each other's successes and take pride in giving back to our communities. Here, your career is more than just a path; it's a journey to making a difference where it truly counts. Ready to make a difference? Apply now to join our team! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Date Posted 17-Jun-2025 Closing Date 23-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. ]]>

Job Title : Senior Statistical Programmer Experience : 7+ years Location : Across INDIA Job Overview At a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. 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 • Master's or Bachelor’s Degree Math’s, Computer science, Statistics • 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 Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role 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. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! #StatisticalProgramming #SAS #DataScience #DataAnalysis #ProgrammingJobs Show more Show less

Summary The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities (incl. submission and postmarketing activities) The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables. About The Role Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for several studies or as a Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. 2. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. 3. May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes. 4. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as SP representative in study- or project-level team. 5. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production. 6. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies). 7. Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Key Performance Indicators 1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers. 2. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team/ project level meetings. Effectiveness of communication and team behaviors as assessed by the team members. 3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. 4. Ability and effectiveness as a programming representative on non-clinical initiatives. Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional Requirement Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Proven communications and negotiation skills, ability to work well with others globally and influence Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

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 Associate 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 QC’d 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 Associate Statistical Programmer will assist in developing, implementing of programming techniques. The Associate Statistical Programmer will ensure SOPs are followed and that timelines and quality standards 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) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team. 5) 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: B.Sc. or Master's degree minimum 1 years of relevant experience required, or a minimum of 6 months of relevant internship experience. Soft skills: Ability to manage timelines and Ability to work independently and within a team environment. Technical skills: Base SAS programming skills, basic knowledge 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 doesn’t 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, let’s 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.com! null Show more Show less

Greetings from You & I Consulting! We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming , this role is your next step forward! To Apply: Send your CV via WhatsApp or Call : Puja- (8250242229) or email your resume at :- puja@careersuni.com Shift - General Shift Open Locations :- Mumbai Pune Bangalore Hyderabad Indore Ahmedabad Key Responsibilities: Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level Design and develop SDTM and ADaM datasets as per CDISC standards Generate Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions Manage and review deliverables for eSubmissions, including Define.xml and reviewer guides Provide technical leadership and mentorship to global programming teams Collaborate closely with biostatistics, data management, and regulatory affairs teams Support and lead Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) projects Ensure programming compliance with SOPs, FDA/EMA guidelines, and quality standards Required Qualifications: Bachelors or Masters degree in Statistics, Computer Science, or a related field 10+ years of SAS programming experience in clinical research or pharmaceutical industry Strong hands-on experience with ADaM, TFLs, eSubmissions, and integrated analysis Deep understanding of CDISC standards, regulatory compliance, and submission requirements Prior experience in oncology, neuroscience, or immunology domains preferred Proven leadership capabilities in managing cross-functional and global teams Excellent communication, project management, and problem-solving skills Preferred Tools & Skills: SAS (Base, Macro, STAT, Graph) Familiarity with SDTM/ADaM IG, FDA submission standards Understanding of regulatory submission formats (eCTD) How to Apply / Schedule an Interview: Send your details via WhatsApp or Call : Puja- (8250242229) in the following format: Full Name: Mobile Number: Email Address: Highest Qualification: Total Experience: Current Organization: Preferred Location: Current CTC: Expected CTC: Notice Period: Note: If the line is busy, please drop a WhatsApp message and we will get back to you at the earliest. Referrals Welcome! Know someone who fits the bill? Share this post and help them grow their career! You & I Consulting Your Career Growth Partner

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 Associate 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 QC’d 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 Associate Statistical Programmer will assist in developing, implementing of programming techniques. The Associate Statistical Programmer will ensure SOPs are followed and that timelines and quality standards 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) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team. 5) 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 : B.Sc. or Master's degree minimum 1 years of relevant experience required, or a minimum of 6 months of relevant internship experience. Soft skills : Ability to manage timelines and Ability to work independently and within a team environment. Technical skills : Base SAS programming skills, basic knowledge 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 doesn’t 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, let’s 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.com!

Salary : 2.2LPA - 14k Change in Hand per month (after deductions of PF,ESI,PT) 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Must have a SAS training Certificate. Role & responsibilities: 1. Providing inputs related to statistical methods for various study design ( two way, parallel, replicate, study state etc) and protocol preparation considering the requirements of BE studies for USFDA, EMEA, CANADA etc submission. 2. Preparation of randomization schedule as per the protocols and applicable SOPs for following study designs ( two way, parallel, replicate, study state etc). 3. Data checking for consistency and outlier analysis for bio-analytical data as well as PK data. 4. Perform statistical analysis of PK data using SAS software for different study designs ( two way, parallel, replicate, study state etc) for USFDA, EMEA, CANADA etc submission. 5. Preparation of statistical report and SAP. 6. Provide sample size estimation/ justification. 7. Statistical outlier detection as per the concerned protocol or regulatory requirements. 8. Response preparation for addressing the regulatory queries related to statistical aspects.

Create and/ or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets Perform development and validation of analysis dataset, tables, listings and figures for both safety and efficacy parameters Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions. Ensure all programs are compliant with the SOPs and project specific guidelines Provide support in developing ad hoc reports as required Maintain quality and timelines of programming related deliverables Update project related documentation regularly Track and follow up on all issues raised. Experience with R Programming/ Python Show more Show less

Job Description : As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose : The Statistical Programmer will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities : SAS Programming : You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy). CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications : MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry. Expertise: Familiarity with statistical principles, CDISC data, and standards. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.

Roles And Responsibilities: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timeframe Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate.

ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy •Develop and/or validate Tables, Listings, and Figures using SAP and mock shells •Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards •Ability to work independently and as part of a team environment •Provide the status of assigned tasks to the Study Lead Programmer •Actively participating in the study meetings and support as backup lead •Identify, communicate, and manage study-based risks and issues within the timeframe •Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance •Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines •Provide guidance, mentoring, and training for junior team members as appropriate

PRINCIPAL STATISTICAL PROGRAMMER (12 15 YEARS) LOCATION: ANYWHERE IN INDIA WORK MODE : HYBRID ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion

Roles And Responsibilities: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion.

Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timeframe Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as the accuracy and reliability of statistical analysis results To ensure that the assigned team members are in compliance with SOPs and training requirements.

Company Description ClinFocus empowers life sciences organizations to accelerate clinical trials through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. As an ISO-certified organization and partner of Medidata Rave, we are committed to excellence and trust in clinical research. We are seeking a highly motivated and skilled Clinical Statistical Programmer to join our dynamic Biometrics team. In this role, you will be instrumental in the development, validation, and maintenance of programs used for the analysis and reporting of clinical trial data. You will work closely with biostatisticians, data managers, and clinical scientists to ensure the accurate and timely delivery of high-quality statistical outputs. Responsibilities: Develop, validate, and maintain SAS programs for the creation of SDTM and ADaM datasets, tables, listings, and figures (TLFs) according to statistical analysis plans (SAPs) and programming specifications. Ability to contribute to the development and implementation of Statistical Analyses Plan Perform quality control (QC) of programs and outputs generated by other statistical programmers to ensure accuracy, consistency, and adherence to company standards and regulatory guidelines. Collaborate with biostatisticians to clarify programming requirements, resolve data issues, and ensure the accurate implementation of statistical methodologies. Contribute to the development and review of programming specifications, mock TLFs, and other study-related documentation. Ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH-GCP) and internal Standard Operating Procedures (SOPs). Participate in team meetings and contribute to discussions regarding study design, data analysis, and reporting strategies. Proactively identify and implement process improvements to enhance efficiency and quality of programming deliverables. Maintain comprehensive documentation of programming activities and version control. May contribute to the development and maintenance of programming standards and macros. Qualifications: Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific field. Minimum of3] years of experience in clinical statistical programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro Language). Strong understanding of CDISC standards, including SDTM and ADaM. Experience with regulatory submissions (e.g., NDA, BLA) is highly desirable. Solid understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements. Excellent attention to detail and strong problem-solving skills. Ability to work independently and as part of a collaborative team. Strong written and verbal communication skills. Experience with other programming languages (e.g., R, Python) is a plus. Knowledge of industry best practices for statistical programming. What We Offer: Opportunity to work on innovative clinical trials across diverse therapeutic areas. A collaborative and supportive work environment. Opportunities for professional growth and development. Competitive salary and benefits package. Show more Show less

The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate to internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs. The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero's standard operating procedures (SOPs) and processes. More specifically, the Senior Statistical Programmer must: Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. Act as a Lead Statistical Programmer on multiple single studies. Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells. Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Indero and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT). Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Indero and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Indero and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs. Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables. Participate to internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/ improvement/validation of standard macros, templates, and programming standards and processes. Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. May also: Mentor more junior Statistical Programmers. Requirements: Education Bachelor’ degree in Statistics, Computing Sciences or a related field; Master’s degree an asset Experience At least 7 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 5 years of Statistical Programming and 2 years acting as a Lead Statistical Programmer. Knowledge And Skills Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications. Excellent working knowledge of SAS; SAS certification an asset. Knowledge of XML programming an asset. Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset. Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. Very organized and detail-oriented, with effective project planning and time management skills. Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. Must be able to work independently and as part of a team. Strong verbal and written communication skills in English; Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required. About Indero Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India. Show more Show less

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based SAS Programmer to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Coordinate communication and issues with Data Management regarding database specifications and data transfers Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field SAS Ceritifcation SAS knowledge required and 1 to 2 years' experience is preferred Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Statistical Programming Manager to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Provide support to project teams on programming matters; Manage programming staff, coordinate task assignments and review activities/progress to ensure high quality delivery; Provide leadership and training for the Programming group; Ensure all projects within the team meet objectives and timelines; and Lead the development of Programming standards, applications and processes to maximize efficiencies. Qualifications Bachelor/Master degree in statistics, mathematics, health informatics, computer science, or related field; Proficiency in SAS programming skills; 5 years of clinical programming experience; Strong communication skills and coordination skills; and Good leadership skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Senior SAS Programmers to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Propose and develop specifications for new projects and serve as a project team leader Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Responsible for the setup, validation and maintenance of mapped databases, integration of external data with associated edit checks, writing programs independently with good quality for use in creating analysis datasets, tables, listings, and figures. Responsible for mapped database setup, validation and maintenance, and external data integration & edit checks, validation, and maintenance Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field 5+ years' eperience with SAS Excellent knowledge of CDISC standards SAS Certification Thorough understanding of the pharmaceutical industry and Federal Regulations regarding electronic records Excellent analytical, written and oral communication skills Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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. Location: Home-based 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.

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 Show more Show less

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions Provide statistical programming and validation for life sciences-related projects including clinical trial datasets and tables, listings, and figures. Access and convert data to SAS datasets and other file types from database management system and PC file formats (e.g., Microsoft Excel, text files). Work with external vendors to develop and/or monitor the content and structure of SAS datasets and other files. Work closely with statisticians and other statistical programmers to generate and validate outputs to ensure accuracy and ensure the quality and soundness of statistical programming algorithms. Provide input to specifications of tabulation and analysis datasets, validation plans, and other related documents Other duties as assigned. Necessary Skills And Abilities In-depth knowledge of statistical programming. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners. Ability to program in SAS and/or R preferred. Educational Requirements Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with 1+ years of relevant work experience. Experience Requirements Experience with CDISC data structures, such as SDTM and ADaM. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Show more Show less