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Job Description
Structured overview of role & requirementsAbout This Role
Lead design and implementation of statistical programming solutions for clinical trials and regulatory submissions.
Develop, validate, and oversee statistical programs ensuring compliance with regulatory standards including CDISC compliance checks using Pinnacle 21.
Mentor junior programmers and collaborate with biostatisticians and clinical teams to align programming outputs with study objectives.
Minimum Requirements
7+ years of statistical programming experience in pharmaceutical, biotechnology, or CRO industry.
Strong hands-on expertise in SAS programming for clinical trial deliverables and analyses.
Basic knowledge or exposure to R programming; willingness to expand proficiency.
Comprehensive understanding of CDISC standards (SDTM and ADaM) and experience using Pinnacle 21 for data validation.
Ideal Candidate Profile
Experienced leader capable of managing complex statistical programming projects and teams within clinical research.
Proficient in regulatory submission standards with hands-on experience ensuring compliance and data quality.
Comfortable operating in a cross-functional environment collaborating with biostatisticians and clinical teams.