Director, Biostatistical Programming

Director, Biostatistical Programming

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio 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 Rayze Bio 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.

Essential duties and responsibilities include the following. Other duties may be assigned.

• 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
• Leverage AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

• 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.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

San Diego - Rayze Bio - 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…