Senior Manager - Statistical Programming

Bristol Myers Squibb; Brisbane (CA); Remote; USD 167,000 - 203,000; Full time

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.

Skills

Programming leadership

SAS expertise

CDISC knowledge

ADaM/TFLs design

Regulatory submission support

Data standard understanding

Clinical data analysis

Risk/issue remediation

Education

Bachelor's degree in statistics/biostatistics/mathematics/computer science/life sciences

Tools

SAS

Pinnacle 21

MS Office

XML

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Senior Managers of Statistical Programming provide comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work effectively within Data & Quantitative Sciences (DQS), with external vendors and members of cross-functional development teams.

Senior Managers of Statistical Programming also support improvement initiatives. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Senior Managers also lead and support the change management process (e.g. communication, training, stakeholder engagement).

Project Responsibilities:

• Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
• Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
• Leads / Supports the electronic submission preparation and review
• Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
• Communicates proactively and effectively around issues and risks and contributes to its remediation

Improvement Responsibilities:

• Identifies, leads, and supports opportunities to enhance processes and technology
• Communicates proactively and effectively around issues and risks and contributes to its remediation

Minimum Requirements:

• 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 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 and applications (e.g. MS office, XML, Pinnacle 21)
• Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)
• Demonstrated ability to work in a team environment with clinical team members

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Brisbane - CA - US: $167,120 - $202,508Cambridge Crossing: $167,120 - $202,508Princeton - NJ - US: $145,320 - $176,099Seattle - WA: $159,850 - $193,702

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year’s Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.