Senior Manager - Statistical Programming

$167.12k - $202.51k

Bristol Myers Squibb

Bristol Myers Squibb seeks a Senior Manager of Statistical Programming to lead programming teams supporting clinical trial data integration, analysis, and regulatory submissions. The role requires comprehensive expertise in SAS, CDISC standards, and drug development processes to deliver compliant analysis datasets and submission components.

Responsibilities

Provide comprehensive programming leadership to clinical project teams and external vendors on strategy and standards deployment
Develop, validate, and maintain complex programs and utilities to regulatory and specification standards
Lead and support electronic submission preparation and regulatory review activities
Develop robust programming specifications including ADaM and analysis documentation
Identify and lead process improvement initiatives with proactive risk communication and remediation

Requirements

Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences
At least 6 years of industry statistical programming experience with regulatory filing support
Proficient in SAS for analysis datasets and tables/figures/listings production
In-depth knowledge of CDISC standards, clinical data structures, and relational databases
Strong understanding of drug development, clinical trial methodology, and regulatory guidance
Demonstrated ability with data processing workflows, eDC systems, SDTM, and ADaM specifications
Team collaboration skills with clinical and cross-functional development members

Compensation: $145,320–$202,508 base (varies by location)

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Vacancy posted 2 days ago

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