Director, Biostatistical Programming

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.

About the role

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.

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 establishing programming and QC processes, and create related SOPs
• Support head of Biostatistical Programming in developing and maintaining 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
• Leverage AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

Requirements

• 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
• Ability 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.

Pay

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.

Benefits

• 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.