Job Description

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.

Purpose

The Senior Manager, Nonclinical Biostatistics, provides leadership for both bioanalytical assay development and drug safety studies.  Contributions in the bioanalytical area include the optimization, validation, and troubleshooting of immunogenicity (IMG), biomarker, and pharmacokinetic assays. Contributions in the drug safety area include reviewing and improving study protocols; analyzing data for general toxicology studies on an as-needed basis; assisting with the development and validation of IMG and genotoxicity assays; and analyzing tumor and mortality data from carcinogenicity studies.  The Senior Manager develops close collaborative relationships with these scientists, providing ongoing collaboration including 1-1 and small group mentoring, as well as larger group applied statistical seminars.  The Senior Manager is strongly encouraged to provide statistical innovation; collaborate with external scientists and statistical experts; present talks at both statistical and scientific conferences; and publish both statistical and collaborative scientific papers.

Primary Responsibilities

• The Senior Manager leads the planning and execution of statistical strategies for nonclinical and clinical bioanalytical assay development. This includes: contributions to study design and protocol development; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring internal study reports, regulatory submissions, and publications.  Provides immediate troubleshooting for failing assays.
• The Senior Manager leads the planning and execution of statistical strategies for both GLP and non-GLP drug safety studies. These include: contributions to study design and protocol review; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring reports, regulatory submissions, and publications.  Animal safety assessment areas include: general toxicology (including pathology), immunotoxicology, genetic toxicology, and carcinogenicity studies.
• Provides statistical education and training to scientists.
• Expeditiously addresses queries from regulatory agencies with high quality responses.
• Presents the results of statistical analyses, their interpretation, and conclusions, to scientists and management in a clear, concise, complete, and transparent manner.

Education/Experience

• PhD degree in Statistics or Biostatistics with 3+ years, or Masters degree with 5+ years, of relevant Pharmaceutical R&D or other related experience.
• Demonstrated knowledge of statistical methodology specific to assay development and drug safety studies.
• Possesses technical knowledge of broader statistical methodology, and ability to appropriately apply it in design and statistical analysis for accurate and high-quality results.
• Excellent computing skills and experience with software packages such as R, RStudio, and SAS.
• Excellent verbal and written communications skills.

• Possesses an effective working knowledge of relevant regulatory guidances and documents.

• Ability to be flexible and adapt quickly to the changing needs of the BMS organization.

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.