Associate Director, Biostatistical Programmer

Bristol Myers Squibb • San Diego, CA

4d • $190,539 - $230,888

About The Position

The Associate 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.

Requirements

• A bachelor's degree required in statistics, mathematics or equivalent with at least 10 years’ experience in pharmaceutical industry; or a master's degree in statistics or computer science with at least 7 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.

Responsibilities

• Oversee vendors' activities, and review vendors' deliverables to ensure quality
• Create/QC SDTM/ADaM data specifications, create/QC CDISC datasets and provide/QC outputs based on protocols/SAP
• 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
• Create SAS macros/applications to streamline processes and enhance efficiency

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.

What This Job Offers

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