Senior Statistical Programmer – FSP (Sponsor-Dedicated)
Location: India (Remote / Pune)
Employment Type: Full-Time, Permanent
Function: Statistical Programming | Biostatistics | Clinical Data Science
Work Model: Fully Remote (India-based)
Job Overview
Cytel is seeking an experienced Senior Statistical Programmer – FSP to join its sponsor-dedicated Functional Service Provider (FSP) model. In this role, you will work fully embedded with a global pharmaceutical sponsor, contributing directly to high-impact clinical development programs across Phase I–IV clinical trials. Supported by Cytel’s global programming and biostatistics expertise, you will play a critical role in clinical trial data analysis, regulatory submissions, and statistical reporting while operating with a high degree of autonomy and ownership.
This position offers a remote work model within India and exposure to global regulatory submissions and advanced analytics in a fast-growing clinical research environment.
Key Responsibilities
Statistical Programming & Clinical Data Analysis
Perform data manipulation, statistical analysis, and reporting for clinical trial safety and efficacy data, including ISS and ISE, using SAS.
Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets in alignment with current regulatory standards.
Generate high-quality Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
Quality Control & Submissions
Conduct production and independent QC/validation programming to ensure accuracy, traceability, and compliance.
Create and review submission-ready deliverables, including define.xml, eCRTs, and associated documentation.
Develop complex ad-hoc analyses and reports using raw clinical trial data.
Cross-Functional & Client Collaboration
Collaborate closely with biostatistics, clinical operations, data management, and sponsor teams to clarify requirements and resolve issues.
Communicate project status, timelines, risks, and deliverables effectively with internal stakeholders and sponsor contacts.
Perform study lead or project lead responsibilities when assigned, managing multiple studies simultaneously.
Required Qualifications
Education
Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related quantitative discipline.
Master’s degree or higher is preferred.
Experience Requirements
Minimum 8 years of SAS 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.
Demonstrated experience supporting Phase I–IV clinical trials.
Prior study lead experience and ability to manage multiple concurrent projects is strongly preferred.
Technical & Domain Expertise
Advanced expertise in SAS programming, including data manipulation, analysis, and reporting.
Strong hands-on experience with CDISC SDTM and ADaM implementation.
Proven experience in QC and validation programming.
Proficiency in efficacy analyses and statistical outputs.
Working knowledge of the drug development lifecycle and regulatory expectations.
Hands-on experience with regulatory submissions, including define.xml and supporting documentation.
Therapeutic area experience in immunology, respiratory, or oncology is an added advantage.
Core Competencies
Excellent analytical, problem-solving, and troubleshooting skills.
High attention to detail with a strong commitment to data quality and compliance.
Ability to deliver high-quality outputs within tight and evolving timelines.
Strong communication skills and ability to work effectively in globally distributed, cross-cultural teams.
Adaptable, proactive, and comfortable working in a sponsor-embedded environment.
Why Join Cytel
Cytel is a global leader in biostatistics, statistical programming, and clinical trial analytics, supporting top pharmaceutical and biotechnology companies worldwide. Through its FSP model, Cytel offers long-term project stability, exposure to cutting-edge clinical research, and continuous professional development in a collaborative and science-driven environment.
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