397 Sdtm Jobs - Page 11

Novo Nordisk Global Business Services ( GBS) India Department - Global Data & Artificial lntelligence Are you passionate about building scalable data pipelines and optimising data workflowsDo you want to work at the forefront of data engineering, collaborating with cross-functional teams to drive innovationIf so, we are looking for a talented Data Engineer to join our Global Data & AI team at Novo Nordisk. Read on and apply today for a life-changing career! The Position As a Senior Data Engineer, you will play a key role in designing, developing, and main-taining data pipelines and integration solutions to support analytics, Artificial Intelligence workflows, and business intelligence. It in...

Designation : Senior Product Manager Experience : 7+ years with at least 3+ years in a Senior role Location: Remote (India) Education Bachelor’s degree, preferably in Computer Science, Electrical Engineering, Physics, Math or any other related discipline; Master’s degree, a plus. Essential skills Exceptional leadership and communication skills, capable of influencing senior executives and driving cross-team alignment. Desired skills Certified Scrum Master (CSM) or Certified Scrum Product Owner (CSPO) with a deep understanding of Agile methodologies. Experience working in regulated environments, including knowledgeof 21 CFR Part 11 compliance. Certifications, if any CSM/CSPO Summary Resource ...

OVERVIEW The Data Engineer will work closely with clients and the eCS Biometrics team to optimize the elluminate platform for end-to-end solutions to aggregate, transform, access and report on clinical data throughout the life cycle of a clinical trial. This includes study design in elluminate, collaboration on specifications, and configuration of the various modules to including Data Central, Clinical Data Analytics and Trial Operational Analytics, Risk-Based Quality Management (RBQM), Statistical Computing Environment (SCE) and Operational Insights. The Data Engineer will be involved in standard ETL activities as well as programming custom listings, visualizations and analytics tools using...

Job Title: Clinical Data Management Developer Experience: 4+ Years Location: Remote Work Hours: 9:00 AM – 6:00 PM IST Contract Type: Short-Term Contract Position Overview We are actively seeking a talented and experienced Clinical Data Management Developer with a strong foundation in Python programming and Electronic Data Capture ( EDC ) systems to support critical clinical research and data operations. This role is ideal for professionals who are passionate about improving the quality and integrity of clinical trial data through innovative technology and clean, reliable code. The successful candidate will have practical experience in tools such as MedDataRave and Inform , and demonstrate a ...

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 deliv...

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 ess...

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 softw...

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,...

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 s...

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 Globa...

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...

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, an...

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 tabl...

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 da...

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 ...

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...

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 ...

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 ...

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 require...

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...

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 timefr...

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 ...

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 Analysi...

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...

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 glob...