Director, Biostatistical Programming

Bristol Myers Squibb • San Diego, CA

18h • $227,418 - $275,577 • Onsite

About The Position

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. 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.

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.
• Be able to work productively in a fast-paced collaborative environment.

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

Benefits

• Medical, pharmacy, dental, and vision care.
• Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio 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 and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

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