Associate Director, Biostatistics

🕒 August 9

🇺🇸 United States – Remote

💵 $189.7k - $229.8k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 37%

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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 • Develop and execute 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 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 • Perform duties involving sitting, reaching, talking, hearing, and occasionally lifting or moving up to 20 pounds

🎯 Requirements

• Advanced degree in Statistics or Biostatistics (PhD or MS) • 6+ years of biostatistics experience in the pharmaceutical/biotech industry with a PhD, or 8+ years with an MS • Experience utilizing AI-enabled tools to improve productivity and work efficiency • Excellent interpersonal and communication skills, with the ability to influence cross-functional stakeholders • Ability to function in a highly regulated environment and adhere to RayzeBio guidelines and SOPs • 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 • Willingness to travel approximately 10% of the time • Evening and weekend work will be involved • Prior experience in oncology clinical development preferred • Prior experience with global regulatory submissions preferred

🏖️ Benefits

• Additional discretionary incentive cash and stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) without a set accrual limit for U.S.-based exempt employees • 11 paid company holidays each year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • 3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year • Summer hours flexibility • Medical, personal, parental, caregiver, bereavement, or military leaves of absence • Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees • Reasonable workplace accommodations/adjustments and ongoing support