Director, Biostatistical Programming

Bristol Myers Squibb EU Policy; San Diego (CA); On-site; USD 227,000 - 276,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan and protections

Paid time off

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is hiring a Director of Biostatistical Programming to lead development of clinical study deliverables, oversee vendor programming, and support internal requests. The successful candidate will report to the Head of Biostatistical Programming.

You will supervise CDISC data packaging, establish programming and QC processes, and develop SAS infrastructure and macros to ensure quality outputs for DSURs, IBs, and regulatory submissions.

Qualifications

• Bachelor's degree in statistics or mathematics or equivalent; 15+ years in pharma or Master's with 12+ years programming experience.
• Oncology experience is required.
• Experience managing CRO relationships and overseeing programmed deliverables.
• Advanced SAS programming and statistical reporting.
• CDISC standards (SDTM/ADaM) knowledge and FDA submission familiarity.
• Knowledge of FDA/ICH regulations and clinical trial methodologies.
• Excellent written and verbal communication; able to work in a fast-paced setting.

Responsibilities

• Oversee vendors' activities and review deliverables for quality.
• Analyze and report clinical trial data to support DSURs, IBs, publications, and FDA briefing documents.
• Collaborate with cross-functional teams to review study documents and perform data reviews.
• Oversee CDISC data package development to support CSRs and submissions.
• Establish programming and QC processes; create related SOPs.
• Develop and maintain SAS programming infrastructure and processes for quality and compliance.
• Create SAS macros and applications to streamline workflows.
• Leverage AI to enhance program, portfolio, or functional performance.

Skills

SAS programming

Statistical reporting

CDISC standards

Project management

Vendor management

Education

Bachelor's degree in statistics, mathematics or equivalent

Master's degree in statistics or computer science

Tools

SAS

SAS Macros

Job description

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

Learn more about RayzeBio: https://careers.bms.com/rayzebio/

The Director of Biostatistical Programming at RayzeBio will be accountable for development of clinical study related deliverables and timelines, oversee study vendors' programming deliverables, and support company internal requests. The successful candidate will report to the Head of Biostatistical Programming.

Job Responsibilities

• Oversee vendors' activities, and review vendors' deliverables to ensure quality
• Participate in reviewing, analyzing, and reporting clinical trial data and generating outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests.
• Collaborate with cross-functional teams to review critical study documents and perform data reviews for ongoing studies
• Oversee CDISC data package development for clinical studies to support CSRs and future regulatory submissions
• Support head of Biostatistical Programming in Establish programming and QC processes, and create related SOPs
• Support head of Biostatistical Programming in Develop and maintain SAS programming infrastructure and process to ensure the quality and compliance in statistical programming deliverables
• Create SAS macros/applications to streamline processes and enhance efficiency
• Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

Education And Experience

• A bachelor's degree required in statistics, mathematics or equivalent with at least 15 years’ experience in pharmaceutical industry; or a master's degree in statistics or computer science with at least 12 years’ programming experience is preferred.
• Oncology therapeutic area experience required.
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• Advanced skills in SAS programming and statistical reporting.
• In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements.
• Advanced knowledge with FDA and ICH regulations and guidelines, and clinical trial methodologies.
• Good written and verbal communication skills.
• Be able to work productively in a fast-paced collaborative environment.
• Willing to travel approximately 10% of the time. Evening and weekend work will be involved.

Physical demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment

The noise level in the work environment is usually moderate.

Compensation Overview

San Diego - RayzeBio - CA: $227,418 - $275,577

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit Offerings Are Subject To The Terms And Conditions Of The Applicable Plans In Effect At The Time And May Require Enrollment.

• 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 Include

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• 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

Based on eligibility*, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People With Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in 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 and RayzeBio will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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/

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.