Associate Director, Biostatistics

🕒 Ontem

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $189.670 - $229.834 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Bristol Myers Squibb

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1887

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Bristol Myers Squibb é uma empresa biofarmacêutica global dedicada a descobrir, desenvolver e oferecer medicamentos inovadores que ajudam os pacientes a superar doenças graves. Suas áreas de foco incluem saúde cardiovascular, terapia celular, imunologia e oncologia. Com um compromisso de transformar os resultados dos pacientes por meio de ciência pioneira, a Bristol Myers Squibb faz parcerias com uma rede mundial de pesquisadores, provedores de saúde e outras partes interessadas. Eles visam liderar a inovação para os pacientes enquanto promovem a diversidade e inclusão em sua força de trabalho.

Descrição

• 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.

🎯 Requisitos

• 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

🏖️ Benefícios

• 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