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