Senior Statistical Programmer – Clinical Research

Job Type: Full-time

Location: Remote

Experience: 7–10 years

Interview Process: 2 Rounds | Virtual

Job Summary

We are seeking an experienced Senior Statistical Programmer with strong hands-on expertise in SAS, ADaM, and TFL programming to support clinical trial programming activities across Phase I–IV studies.

The ideal candidate will have strong knowledge of CDISC standards, clinical trial programming processes, Safety and Efficacy analyses, and regulatory requirements. Experience with R programming and study-level programming leadership is preferred.

Key Responsibilities

- Contribute to or lead statistical programming activities for Phase I–IV clinical trials.
- Develop and validate ADaM datasets, Tables, Listings, and Figures (TFLs) according to specifications.
- Support programming activities for Safety and Efficacy analyses.
- Develop and/or review programming specifications aligned with Statistical Analysis Plans (SAPs).
- Collaborate with Biostatistics, Data Management, Clinical, and other cross-functional teams.
- Participate in study meetings and communicate programming progress, risks, and issues.
- Ensure compliance with CDISC, GCP, ICH, company, and departmental standards.
- Perform QC and validation checks to ensure accuracy, reliability, and quality of statistical outputs.
- Participate in or lead eCRF and data structure reviews.
- Support audit readiness and regulatory submission activities.




- Lead study-level programming activities and coordinate with other programmers.
- Mentor and guide junior programmers.
- Contribute to process improvement, standardization, and programming best practices.
- Deliver high-quality and timely programming outputs for key study milestones, including DMCs, interim analyses, publications, CSRs, and regulatory submissions.

Required Qualifications
- 7–10 years of relevant experience in clinical statistical programming.
- Strong hands-on experience with SAS programming.
- Strong experience in ADaM and TFL programming.
- Experience supporting both Safety and Efficacy analyses.
- Solid knowledge of CDISC SDTM and ADaM standards.
- Good understanding of GCP, ICH, and regulatory requirements.
- Experience independently delivering high-quality statistical programming outputs.
- Strong analytical, problem-solving, communication, and collaboration skills.
- Experience coordinating or leading statistical programming activities is highly desirable.

Preferred Qualifications
- Experience with R programming.
- Experience supporting multiple phases of clinical trials.
- Experience with regulatory submissions and audit readiness.
- Experience mentoring junior statistical programmers.
- Experience working with cross-functional clinical research teams.

How to Apply Interested candidates are requested to send their updated CV/Resume to:

[email protected]

Please mention “Senior Statistical Programmer” in the subject line.

Pay: Up to ₹800,000.00 per year

Work Location: In person

📌 Senior Statistical Programmer – Clinical Research (Hyderabad)
🏢 Exelo Technologies
📍 Hyderabad