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Job Description
Structured overview of role & requirementsAbout This Role
Develop, validate, and maintain complex statistical programs (SAS, R, or similar) to support clinical trial analysis and reporting in phase IV and post-approval studies.
Collaborate with biostatisticians and cross-functional teams to interpret study requirements and implement statistical analyses accurately.
Mentor junior programmers and assist in training on programming techniques and best practices.
Minimum Requirements
2+ years of statistical programming experience in pharmaceutical, biotechnology, or CRO industry.
Strong hands-on expertise in SAS programming supporting clinical trial deliverables and analyses.
Basic knowledge or exposure to R programming with willingness to improve.
Comprehensive understanding of CDISC standards including SDTM and ADaM; experience with Pinnacle 21 for CDISC compliance and data validation.
Ideal Candidate Profile
Experienced in producing validated, production-quality statistical programming code within regulated clinical trial environments.
Able to collaborate effectively with biostatisticians and cross-functional teams to ensure compliance with industry standards (ICH/GCP).
Capable of mentoring peers and contributing to team skill development on complex programming and regulatory compliance.