Senior Statistical Programmer – FSP (Sponsor-Dedicated)
Location: India (Remote)
Employment Type: Full-Time
Work Model: Fully Remote
Functional Area: Biostatistics | Statistical Programming | Clinical Data Analytics
Industry: Pharmaceutical | Biotech | Clinical Research
About the Role
The Senior Statistical Programmer – FSP will work in a sponsor-dedicated model, embedded full-time with a leading global pharmaceutical organization while receiving continuous functional and technical support from Cytel. This role offers the opportunity to contribute directly to high-impact clinical development programs while operating with autonomy, accountability, and scientific rigor.
The position supports Phase I–IV clinical trials and requires advanced expertise in SAS programming, CDISC standards (SDTM and ADaM), and clinical trial data analysis and reporting. This is a fully remote opportunity based in India.
Key Responsibilities
Perform advanced data manipulation, analysis, and reporting of clinical trial safety and efficacy data, including ISS and ISE deliverables, using SAS.
Develop, validate, and maintain SDTM and ADaM datasets, analysis files, and associated Tables, Listings, and Figures (TLFs).
Execute production and QC/validation programming to ensure high-quality, submission-ready outputs.
Generate complex ad hoc analyses and reports using raw clinical trial data.
Apply strong expertise in efficacy analysis across therapeutic areas and trial phases.
Create, review, and support regulatory submission documents, including define.xml and eCRTs.
Collaborate closely with cross-functional internal teams and sponsor stakeholders to clarify specifications, resolve issues, and communicate project status.
Perform study lead or programming lead responsibilities, including oversight of deliverables, timelines, and quality, as required.
Demonstrate flexibility and adaptability in a dynamic project environment with evolving priorities.
Contribute as a proactive team member within global, cross-cultural, and distributed teams.
Required Qualifications
Education
Bachelor’s degree in Statistics, Mathematics, Computer Science, Biostatistics, or a related scientific discipline.
Master’s degree or higher is an advantage.
Experience
Minimum 8 years of hands-on SAS statistical programming experience in the pharmaceutical or biotechnology industry with a bachelor’s degree.
Minimum 6 years of relevant experience with a master’s degree or higher.
Prior experience as a study lead statistical programmer, including management of multiple concurrent studies, is strongly preferred.
Technical & Functional Skills
Advanced proficiency in SAS programming for clinical trial data analysis.
Strong hands-on experience with CDISC SDTM and ADaM standards and implementation.
Proven expertise in QC and validation programming.
Solid understanding of efficacy analyses and clinical trial methodologies.
Experience supporting regulatory submissions, including define.xml and associated documentation.
Familiarity with the drug development lifecycle and end-to-end clinical data workflows.
Exposure to immunology, respiratory, or oncology studies is highly desirable.
Excellent analytical, problem-solving, and troubleshooting capabilities.
Ability to deliver high-quality outputs under tight timelines and regulatory constraints.
Work Environment & Collaboration
This role requires the ability to work independently in a fully remote environment, while collaborating effectively with globally distributed teams across time zones and cultures. Strong communication skills and a proactive mindset are essential for success.
Why Join This Opportunity
Work in a sponsor-dedicated FSP model with direct impact on global clinical development programs.
Fully remote role offering flexibility and work-life balance.
Exposure to cutting-edge clinical research and advanced statistical methodologies.
Opportunity to grow within a high-performing, scientifically driven environment.
Gujarat :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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China | Quarry Bay |Liaoning :
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Peru | Argentina |Brazil :
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Tallinn |Hà Nội :
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Riyadh | Rabigh | King Abdullah Economic City | Najran | Jeddah | Khulais |Kuala Lumpur :
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South Africa | Midrand |Nišava District :
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