Senior Manager, Statistical Programming

Bristol Myers Squibb • Princeton, NJ

21h • Remote

About The Position

Bristol Myers Squibb is seeking a Senior Manager, Statistical Programming to provide programming expertise to clinical project teams. This role supports the development, regulatory approval, and market acceptance of company products by designing, developing, and implementing technical solutions for integrating, analyzing, and reporting clinical data. The position involves developing collaborative relationships within the Global Biometrics and Data Sciences organization, with external vendors, and with members of cross-functional development teams. Key responsibilities include deploying programming strategies, standards, specifications, and programmed analyses to comply with regulatory requirements, standard operating procedures, and work practices. The role also entails developing, validating, troubleshooting, and maintaining programs and utilities in accordance with pre-defined specifications and standards, supporting electronic submissions through preparation and review, and developing programming specifications and reviewing key planning documents such as statistical analysis plans, data presentation plans, and data review plans to align with project objectives. Ensuring clarity and completeness of programming assumptions and requirements, and assessing document robustness and impact on programming activities are also crucial aspects of this position.

Requirements

• Master’s degree or foreign equivalent in Statistics, Business and Information Systems, Industrial Management, Computer Science, or a related field.
• Three (3) years of related work experience as a Statistician or related occupation.
• Three (3) years of experience using R for producing derived analysis datasets and TFLs.
• Three (3) years of experience implementing clinical data structures including Clinical Data Interchange Standards Consortium standards and relational databases.
• Three (3) years of experience utilizing SAS, XML, and Pinnacle 21 to produce analysis datasets and TFLs.
• Three (3) years of experience processing upstream data including multiple data forms, workflows, eDC, and SDTM.
• Three (3) years of experience providing downstream deliverables such as ADaM, TFLs, and e-submission components.

Responsibilities

• Provide programming expertise to clinical project teams to support the development, regulatory approval, and market acceptance of company products.
• Design, develop, and implement technical solutions for integrating, analyzing, and reporting clinical data.
• Develop collaborative relationships within the Global Biometrics and Data Sciences organization, external vendors, and members of cross-functional development teams.
• Deploy programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, standard operating procedures, and work practices.
• Develop, validate, troubleshoot, and maintain programs and utilities in accordance with pre-defined specifications and standards.
• Support electronic submissions through preparation and review.
• Develop programming specifications and review key planning documents such as statistical analysis plans, data presentation plans, and data review plans to align with project objectives.
• Ensure clarity and completeness of programming assumptions and requirements.
• Assess document robustness and impact on programming activities.

Benefits

• Annual discretionary bonus
• Health Coverage: 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 US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager