Manager, Statistical Programming
About The Position
Bristol Myers Squibb Company is hiring a(n) Manager, Statistical Programming in Princeton, NJ. This role provides programming expertise to clinical project teams to support the development, regulatory approval, and market acceptance of Bristol Myers Squibb products. The position involves designing, developing, and implementing technical solutions for analyzing and reporting clinical data using industry tools. Key responsibilities include developing analysis datasets, specifications, and outputs such as safety and efficacy tables, figures, listings, and submission packages. The role also supports electronic data submission activities in compliance with regulatory requirements and collaborates with cross-functional teams and external vendors to ensure quality deliverables, provide programming guidance, and support improvement initiatives within Global Biometrics & Data Sciences (GBDS). The position is 100% telecommuting permitted, and the candidate may reside anywhere in the U.S.
Requirements
- Bachelor’s degree or foreign equivalent in Statistics, Biostatistics, Mathematics, Computer Science, Pharmaceutical Science, or a related field, and five (5) years of progressive post-baccalaureate work experience.
- Five (5) years of experience in developing analysis data model (ADaM) specifications and derived datasets.
- Five (5) years of experience in creating SAS programs to generate datasets, tables, listings, and figures.
- Five (5) years of experience in using Pinnacle 21 Enterprise to generate regulatory-compliant submission packages.
- Five (5) years of experience in applying CDISC standards, MedDRA, NCI CTCAE v5, and WHO Drug Dictionary.
- Five (5) years of experience in processing upstream data, including source and SDTM data, for ADaM dataset creation.
- Five (5) years of experience in applying knowledge of clinical trial development, statistical programming, and data submissions.
- Five (5) years of experience in managing vendors for outsourced programming deliverables.
Responsibilities
- Provide programming expertise to clinical project teams to support the development, regulatory approval, and market acceptance of Bristol Myers Squibb products.
- Design, develop, and implement technical solutions for analyzing and reporting clinical data using related industry tools.
- Develop analysis datasets, specifications, and outputs including safety and efficacy tables, figures, listings, and submission packages.
- Support electronic data submission activities in compliance with regulatory requirements.
- Collaborate with cross-functional teams and external vendors to ensure quality deliverables, provide programming guidance, and support improvement initiatives within Global Biometrics & Data Sciences (GBDS).
Benefits
- Annual discretionary bonus
- Healthcare: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits: Paid Time Off
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
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What This Job Offers
Job Type
Full-time
Career Level
Manager
