Job Description
Job Title: Senior Statistical Programmer (Contract)
Location / Work Arrangement: Remote (India-based)
Contract Length: 12 months
Start Date: March, Immediate joiners.
Role Overview
This is a contract role requiring strong technical capability in clinical/statistical programming. The focus is on hands-on delivery, regulatory-quality outputs, and the ability to work independently on complex programming assignments.
Key Responsibilities
- Develop SAS programs for analysis datasets (SDTM / ADaM) and TLF outputs
- Validate analysis datasets and programming outputs
- Support preparation and review of e-submission deliverables
- Review planning documents (SAPs, data plans) and assess programming impact
- Collaborate with vendors on standards and data/file transfers
- Ensure high-quality deliverables aligned with regulatory and internal standards
- Identify opportunities for efficiency, standardisation, and process improvement
- Lead programming activities independently
- Contribute to broader process improvement initiatives
Required Skills & Experience
- Bachelor's degree in Statistics, Biostatistics, Computer Science, Mathematics, or Life Sciences
- Minimum 8 years experience in clinical/statistical programming
- Strong analytical programming capability
- In-depth knowledge of CDISC standards and relational databases
- Experience with tools such as MS Office, XML, and Pinnacle 21
- Strong upstream data handling experience (eDC, SDTM)
- Proven experience producing ADaM datasets, Define.xml, and submission-ready deliverables
- Solid understanding of regulatory standards, clinical data, and terminology
- Strong communication and collaboration skills
Preferred Experience
- 710+ years clinical/statistical programming experience
- Experience supporting regulatory submissions (NDA, BLA, MAA)
- Exposure to R and Linux environments
Additional Notes
- Strong hands-on ADaM and SDTM dataset creation experience is essential
- Proven capability in complex TLF programming
- Experience working within regulatory submission timelines is highly valued
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
