Associate Director, Biostatistics

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $173.2k - $209.9k / 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 lead biostatistician for clinical oncology projects • Develop and execute statistical strategies, study designs, and analyses • Provide biostatistical support for interactions with global health authorities, including FDA and EMA • Contribute to briefing documents, agency-question responses, and submission dossiers • Partner with multidisciplinary project teams to align objectives and ensure timely communication • Identify and implement solutions to statistical and data-analysis issues for clinical trials and regulatory submissions • Author and own protocol statistical sections, statistical analysis plans, and TLF shells • Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs • Partner with statistical programmers on regulatory requests, DSUR/IB updates, publications, and ad hoc analyses • Participate in sponsor review of ongoing clinical data to ensure integrity and identify efficacy and safety trends • Explore, pilot, and help implement AI-enabled tools and workflows to improve quality control and operational efficiency • Support development of radiopharmaceutical therapies through early-phase dose finding and optimization, registrational trials, and regulatory submissions

🎯 Requirements

• Advanced degree in Statistics or Biostatistics (PhD or MS) • 6+ years of biostatistics experience in the pharmaceutical/biotech industry for PhD holders, or 8+ years for MS holders • Experience in oncology clinical development • Experience applying Bayesian methods in a clinical development setting • Proficiency in statistical software, including SAS, R, and EAST, including simulation for trial design • Working knowledge of CDISC standards, including SDTM and ADaM • Ability to review and interpret key statistical outputs • Ability to oversee vendors and ensure the quality, timeliness, and compliance of biometrics deliverables • Solid understanding of GCP, ICH guidelines, and global regulatory requirements • In-depth knowledge of statistical methods for oncology trials • Excellent interpersonal and communication skills • Ability to function in a highly regulated environment and adhere to RayzeBio guidelines and SOPs • Willingness to travel approximately 10% of the time • Occasional evening and weekend work may be required

🏖️ Benefits

• Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) for U.S.-based exempt employees • 11 paid company holidays per year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees in Puerto Rico • 3 optional holidays for non-exempt employees, RayzeBio employees, and employees in Puerto Rico • Paid sick leave, subject to 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 • Reasonable workplace accommodations/adjustments and ongoing support for people with disabilities • Additional discretionary incentive cash and stock opportunities may be available