Senior Statistical Programming Leader

Bristol Myers Squibb

Brisbane (CA)

Remote

USD 167,000 - 203,000

Full time

5 days ago

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Benefits offered by this job

Comprehensive benefits

Flexible work options

Job summary

Bristol Myers Squibb seeks a Senior Manager of Statistical Programming to lead programming for clinical projects, design and implement data analysis solutions, and support regulatory submissions. The role collaborates with Data & Quantitative Sciences, vendors and cross-functional teams.

It emphasizes risk identification, remediation strategies, and change management while contributing to continuous process improvements.

Qualifications

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
At least 6 years programming experience in industry including support of significant regulatory filings.
Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
Broad expertise in statistical programming and in developing computing strategies.
In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases.
Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools (MS Office, XML, Pinnacle 21).

Responsibilities

Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards and analyses.
Independently develops, validates, troubleshoots, and maintains complex programs and utilities.
Leads / Supports the electronic submission preparation and review.
Develops unambiguous and robust programming specifications (e.g. ADaM specifications).
Reviews planning documents to align with objectives and ensures clarity and completeness of programming requirements.
Communicates proactively around issues and risks and contributes to remediation.
Identifies, leads, and supports opportunities to enhance processes and technology.