Associate Director, Biostatistics

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $189.7k - $229.8k / year

⏰ Full Time

🟠 Senior

👔 Director

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Serve as the lead biostatistician for clinical oncology projects, developing and executing statistical strategies, study designs, and analyses. • Collaborate with multidisciplinary project teams to ensure timely communication and alignment of objectives. • Identify and implement solutions to statistical and data analysis issues related to clinical trials and regulatory submissions. • Author and own key statistical documents and outputs, including protocol statistical sections, SAPs, and TLF shells. • Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs. • Work with internal programmers to support regulatory requests, DSUR/IB updates, and ad-hoc analyses. • Participate in internal sponsor review of ongoing clinical data. • Explore and pilot AI initiatives that enhance quality control and operational efficiency. • Travel approximately 10% of the time. • Perform occasional evening and weekend work.

🎯 Requirements

• Advanced degree in Statistics or Biostatistics (PhD or MS) • 8+ years of biostatistics experience in the pharmaceutical/biotech industry with a PhD, or 10+ years with an MS • Experience utilizing AI-enabled tools to improve productivity and work efficiency • Familiarity with statistical programming tools such as SAS and/or R • Working knowledge of CDISC standards (SDTM/ADaM) • Ability to review and interpret key statistical outputs • Ability to oversee vendors and ensure quality, timeliness, and compliance of biometrics deliverables • Solid understanding of GCP, ICH guidelines, and regulatory requirements • Excellent interpersonal and communication skills, with ability to influence cross-functional stakeholders • Ability to function in a highly regulated environment and adhere to RayzeBio guidelines and SOPs • Prior experience in oncology clinical development preferred • Prior experience with global regulatory submissions preferred • Willingness to travel approximately 10% of the time • Availability for evening and weekend work

🏖️ Benefits

• Additional incentive cash and stock opportunities (based on eligibility) • Medical, pharmacy, dental, and vision care • BMS Well-Being Account • BMS Living Life Better • 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 • Survivor support • Flexible time off (unlimited, with manager approval) for US Exempt Employees • 11 paid national holidays for US Exempt Employees • 160 hours annual paid vacation for Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees • 11 national holidays and 3 optional holidays for Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees • Unlimited paid sick time, based on eligibility • Up to 2 paid volunteer days per year, based on eligibility • Summer hours flexibility, based on eligibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs • Annual Global Shutdown between Christmas and New Years Day • Reasonable workplace accommodations/adjustments and ongoing support