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Senior Manager – Statistical Programming
Bristol Myers Squibb. Provide comprehensive programming leadership and support to clinical project teams and vendors .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in statistical programming and regulatory compliance, with a strong focus on developing and validating complex programs for clinical data analysis and submission. Proven ability to lead programming initiatives, enhance processes, and foster collaboration across cross-functional teams.
Highest-signal resume keywords
Statistical ProgrammingSAS ProficiencyClinical Trial MethodologyCDISC Standards KnowledgeRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical ProgrammingSASADaM SpecificationsData Presentation PlansStatistical Analysis PlansRelational DatabasesEDC ProcessingSDTM DeliverablesProgramming SpecificationsTroubleshooting
Soft Skills
CommunicationCollaborationProblem-SolvingStakeholder EngagementChange Management
Tools & Technologies
MS OfficeXMLPinnacle 21
Industry Keywords
Drug Development ProcessClinical Data StructureRegulatory GuidanceBiostatisticsLife Sciences
About the role
Key responsibilities & impact- Provide comprehensive programming leadership and support to clinical project teams and vendors
- Deploy programming strategies, standards, specifications, and programmed analyses complying with regulatory requirements, SOPs, and work practices
- Independently develop, validate, troubleshoot, and maintain complex programs and utilities
- Lead or support electronic submission preparation and review
- Develop robust programming specifications, including ADaM specifications
- Review statistical analysis plans, data presentation plans, and data review plans
- Align programming activities with project objectives and assess document robustness and completeness
- Communicate issues and risks proactively and contribute to remediation
- Identify, lead, and support opportunities to enhance processes and technology
- Support change management through communication, training, and stakeholder engagement
- Develop collaborative relationships within Data & Quantitative Sciences, with external vendors, and across cross-functional development teams
Requirements
What you’ll need- 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
- For US positions, US military experience will be considered towards industry experience
- Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in analysis and submission of clinical data
- Broad expertise in statistical programming and developing computing strategies
- In-depth understanding of clinical data structure, including CDISC standards, and relational databases
- Demonstrated proficiency using SAS to produce analysis datasets and TFLs
- Experience using MS Office, XML, Pinnacle 21, and other software tools and applications
- Demonstrated ability processing upstream data, including multiple data forms, workflows, eDC, and SDTM
- Demonstrated ability providing downstream deliverables, including ADaM, TFLs, and e-submission components
- Demonstrated ability to work in a team environment with clinical team members
Benefits
Comp & perks- Comprehensive wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) for U.S.-based exempt employees
- 11 paid company holidays each year
- 160 hours of paid vacation annually for eligible new hires
- 3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees
- Paid sick leave, depending on eligibility
- Up to two paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- Annual Global Shutdown between Christmas Day and New Year's Day
- Additional discretionary incentive cash and stock opportunities
- Workplace accommodations/adjustments and ongoing disability support