Head Of Early Development Biostatistics

Bristol Myers Squibb Princeton , NJ 08544

Posted 2 months ago

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Head of Early Development, Biostatistics will lead Biometrics Sciences globally for all therapeutic areas in Early Development. This role will directly supervise biostatistical leaders as well as single-contributor biostatisticians in support of research and early development (R&ED) activities. The individual will be accountable for biostatistical strategy, will contribute to clinical development strategies, and will represent the Global Biometrics and Data Science group in R&ED. This individual will have approval responsibilities for all statistical contributions and will be playing critical role in governance and decision making.

Key Responsibilities

  • This role will directly supervise biostatistical leaders as well as single-contributor biostatisticians in support of R&ED activities.

  • Contribute strategically to clinical development plans and regulatory strategies to ensure the company's clinical programs are optimally designed and executed

  • Oversee the implementation of appropriate experimental and clinical trial designs, including dose optimization strategies and go-no-go decision, the creation and maintenance of validated databases, and the generation of accurate and timely statistical analyses

  • Ensure cross-functional collaboration and development of department staff

  • Interacts and manages KOLs/CROs and represents the company in external scientific and industry forums.

  • Contributes to vision and strategy in the development and growth of statistical functional capabilities.

  • Seeks and establishes new collaborations with cross-functional areas including data science and digital health; maintains existing stakeholder collaborations

  • Shapes the future of the function through identification of new directions, new solutions, and integrating them within the company.

  • Establish partnerships with drug development stakeholders and other key matrix partners in early and late development

  • Utilize professional network to build and maintain talent pipeline.

Qualification and Experience

  • Ph.D. in Statistics or Biostatistics

  • 12+ years of experience in biostatistics in the pharmaceutical industry at all phases of clinical development

  • Minimum 8 years management experience

  • Proven experience in serving as a project biostatistician, supporting regulatory engagement, and meeting with health authorities (e.g, FDA, EMA) in either late-stage development or early Translational development

  • Demonstrated expertise in advanced statistical methods and clinical trial design

  • In depth knowledge of regulatory guidelines in pharmaceutical development

  • Excellent organizational and communication skills

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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Head Of Early Development Biostatistics

Bristol Myers Squibb