Job Summary

Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn current skills from working in a team environment.

This role is full-time and fully-remote. The successful candidate may be based in India.

Responsibilities

The following areas of expertise will be aligned to the role...

- Statistical expertise and scientific leadership
- Leadership and people development
- Compliance, quality and governance
- Communication and influence

Qualifications

- BSc in Mathematics, Computer Science or a related discipline.
- Strong experience in clinical trial statistics and SAS programming, supporting Phase II/III studies across analysis, reporting, and regulatory submission activities.
- Hands-on expertise in SDTM, ADaM, TLF development and validation, with strong knowledge of CDISC standards and submission-ready deliverables.




- The successful candidate will have experience supporting regulatory submissions, including NDA/BLA, MAA, ISS/ISE, eCTD packages, define.xml, reviewers guides, and responding to regulatory authority queries.
- The ability to interpret protocols, SAPs, shells, and statistical specifications, translate requirements into high-quality analysis outputs, and identify issues proactively.
- Strong understanding of submission QC, traceability, data integrity, and programming best practices, including independent validation, macro usage, documentation, and adherence to SOPs.
- Proven ability to work independently with statisticians, programmers, data management, medical writing, and sponsor teams, manage timelines, communicate risks early, and deliver high-quality outputs under tight submission deadlines.
- MSc in Mathematics, Computer Science or a related discipline is advantageous.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Statistical Programmer (India)
🏢 PHASTAR
📍 India