Senior Statistical Programmer – FSP (Sponsor Dedicated | Remote – India)
Location: India
Work Model: Fully Remote
Employment Type: Full-Time
Experience Required:
Minimum 8 Years of SAS Programming Experience in Pharma/Biotech (Bachelor’s Degree)
Minimum 6 Years of Experience (Master’s Degree or Higher)
About the Organization
Cytel is a global leader in advanced analytics, biostatistics, and clinical trial methodology, partnering with pharmaceutical and biotechnology companies to accelerate drug development. Through its Functional Service Provider (FSP) model, Cytel embeds experienced statistical programmers directly within sponsor teams to support regulatory-compliant clinical trial execution.
Role Overview
The Senior Statistical Programmer – FSP is a sponsor-dedicated role fully embedded within a global pharmaceutical client. This position plays a critical role in supporting Phase I–IV clinical trials, ensuring high-quality statistical programming deliverables aligned with CDISC standards and global regulatory submission requirements.
The ideal candidate brings deep expertise in SAS programming, SDTM and ADaM dataset development, TLF generation, and regulatory submissions. This role requires strong analytical capabilities, cross-functional collaboration skills, and experience working in globally distributed teams.
Key Responsibilities
Perform advanced data manipulation, statistical analysis, and reporting for clinical trial datasets (safety and efficacy including ISS/ISE).
Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets.
Generate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
Conduct production programming and independent QC/validation programming.
Create complex ad-hoc reports using raw clinical data.
Support efficacy analysis and statistical reporting activities.
Contribute to regulatory submission documentation including define.xml and eCRTs.
Communicate with cross-functional teams and sponsor stakeholders regarding specifications, timelines, and deliverables.
Perform study lead responsibilities when required, including oversight of multiple concurrent projects.
Ensure compliance with global regulatory standards and sponsor SOPs.
Required Qualifications
Bachelor’s Degree in Statistics, Computer Science, Mathematics, Biostatistics, or related quantitative field.
8+ years of SAS programming experience in pharmaceutical or biotech clinical trials (Bachelor’s Degree).
6+ years of experience with a Master’s Degree or higher.
Strong expertise in SAS for data manipulation, analysis, and reporting.
Proven experience implementing CDISC SDTM and ADaM standards.
Hands-on experience in regulatory submissions including define.xml.
Solid QC and validation programming experience.
Strong understanding of the drug development lifecycle.
Preferred Experience
Study lead experience managing multiple clinical trials.
Experience in immunology, respiratory, or oncology therapeutic areas.
Advanced efficacy analysis expertise.
Strong ad-hoc reporting and troubleshooting capabilities.
Experience working within globally dispersed, cross-cultural teams.
Core Competencies
Advanced SAS Programming
CDISC SDTM & ADaM Implementation
Clinical Trial Data Analysis (Phase I–IV)
Regulatory Submission Support
QC & Validation Programming
Statistical Reporting & TLF Development
Cross-Functional & Global Team Collaboration
Why Consider This Opportunity
Fully remote flexibility within India.
Sponsor-dedicated model with high ownership and autonomy.
Exposure to global Phase I–IV clinical development programs.
Opportunity to contribute to next-generation therapies and regulatory submissions.
Professional development within a specialized biostatistics and statistical programming environment.
Job Category:
Biostatistics & Statistical Programming
Clinical Data Science
Pharmaceutical Clinical Development
CDISC & Regulatory Submissions
Remote Pharma Jobs India
This Senior Statistical Programmer – FSP role is designed for experienced clinical SAS programmers seeking advanced sponsor-facing responsibilities, regulatory submission exposure, and leadership opportunities within global pharmaceutical development programs.
Uttar Pradesh :
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Frank Scottile Blvd |Missouri :
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Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Carlow |Republic of Ireland :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Italy |Lombardy :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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Bangkok |Israel :
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Midrand | South Africa |Nišava District :
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Santiago |Bosnia and Herzegovina :
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