Associate Director, Biostatistics

🕒 il y a 2 jours

🇺🇸 États-Unis – Télétravail

💵 $173 217 - $209 899 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

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Cette entreprise a parrainé des visas H1B par le passé.

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Bristol Myers Squibb

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10 000+ employés

Fondée en 1887

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Bristol Myers Squibb est une entreprise biopharmaceutique mondiale engagée dans la découverte, le développement et la distribution de médicaments innovants qui aident les patients à surmonter des maladies graves. Leurs domaines de prédilection incluent la santé cardiovasculaire, la thérapie cellulaire, l'immunologie et l'oncologie. Avec un engagement à transformer les résultats pour les patients grâce à une science de pointe, Bristol Myers Squibb collabore avec un réseau mondial de chercheurs, de prestataires de soins de santé et d'autres parties prenantes. Ils visent à être des leaders dans l'innovation pour les patients tout en favorisant la diversité et l'inclusion au sein de leur personnel.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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

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