Senior Statistical Programmer – FSP
Location: Remote – Pune, Maharashtra, 411038, IN
Job Type: Full-Time
Department: Statistical Programming – FSP
Job ID: 640
Posting Date: April 10, 2025
Position Overview
In this sponsor-dedicated role, you will work fully embedded within a global pharmaceutical client, playing a key part in clinical innovation and patient-centered outcomes. As a Senior Statistical Programmer, you'll lead or support programming activities for one or more Phase I-IV trials, particularly focusing on SAS programming and CDISC standards like ADaM and SDTM. The position offers a fully remote work option within India.
Key Responsibilities
Perform data manipulation, analysis, and reporting using SAS for both safety and efficacy data.
Generate and validate SDTM and ADaM datasets, as well as tables, listings, and figures (TLFs).
Conduct QC and validation programming, including complex ad-hoc reports.
Contribute to pooled data analysis and project-level data integration.
Support regulatory submissions, including creation and review of define.xml and other eCRT documents.
Act as study lead programmer on multiple projects as needed.
Collaborate effectively across internal and client-facing teams to ensure delivery excellence.
Adapt quickly to changing priorities, displaying a flexible and problem-solving mindset.
Required Qualifications
Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field.
8+ years of SAS programming experience with clinical trial data (or 6+ years with a Master’s degree).
Demonstrated study lead experience; ability to manage multiple projects preferred.
Strong knowledge of CDISC ADaM and efficacy analysis.
Submissions experience including define.xml and related documents.
Familiarity with clinical drug development lifecycle.
Excellent QC/validation, troubleshooting, and ad-hoc reporting skills.
Strong communication and teamwork in globally dispersed environments.
Preferred Qualifications
Experience in immunology or neuroscience therapeutic areas.
Exposure to the submission process and regulatory interactions.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Japan | Saitama |Tokyo :
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