Senior Statistical Programmer

Planet Pharma is seeking Senior Statistical Programmers to work remotely on contract in India. This is a long term assignment with the potential to go permanent!

Key Responsibilities Develop high‑quality SAS programs for ADaM/SDTM datasets and TLF outputs. Perform validation of analysis datasets, tables, listings, and figures. Support preparation and review activities for electronic regulatory submissions. Review key planning documents (e.g., SAPs, data plans) and assess programming requirements and impacts. Collaborate with external vendors on standards, data transfers, and deliverables. Ensure all programming outputs meet global regulatory and quality standards. Identify and implement process improvements to drive efficiency and consistency. Independently lead assigned programming activities and project components. Contribute to broader functional and cross‑functional process enhancement initiatives.

Required Skills & Experience Bachelor’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a Life Science discipline. Minimum

8 years of statistical programming experience

within clinical research. Strong proficiency in analytical SAS programming. Deep understanding of

CDISC standards , including SDTM and ADaM. Experience working with relational databases and clinical data structures. Proficiency with MS Office, XML tools, and Pinnacle 21. Expertise in upstream data processing (eDC, SDTM development). Demonstrated experience producing ADaM datasets, Define.xml, and regulatory submission deliverables. Solid knowledge of regulatory expectations, clinical terminology, and standard medical tests. Strong communication and teamwork skills with a collaborative mindset.

Preferred Qualifications 7–10+ years

of clinical/statistical programming experience. Experience supporting major regulatory submissions (NDA, BLA, MAA). Familiarity with R programming and Linux operating environments. Strong hands‑on experience in ADaM and SDTM dataset creation. Proven capability in complex TLF programming. Experience with regulatory submission requirements is highly desirable.