Sr. Manager, Biostatistics (R1547818-en-us-6)
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.
BMS is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.
The Cell Therapy CMC Biostatistics group supports the statistical and quantitative elements related to Cell Therapy Process and Analytical CMC activities - development, regulatory submissions and post-approval commercial manufacture. The role of CMC Biostatistics is being increasingly recognized across the Pharma / Biotech / Medical Devices industry, both from a business as well as from a regulatory perspective, and so this role provides a wonderful opportunity for learning and growth within a rapidly expanding therapeutic area.
- 2+ years of experience as a Non-clinical / CMC Statistician along with an advanced degree in a quantitative discipline (Statistics, Chemical / Industrial Engineering, Applied Mathematics)
- Working knowledge of manufacturing processes and analytical methods in the biotech industries
- Communication and collaborative skills to work in a fast-paced, team environment
- Strong proficiency in at least one statistical software package (such as SAS, JMP, Minitab, R)
Proficiency in at least two, as well as familiarity with most of the following:
- Statistical aspects of pharmaceutical regulations / guidance (some prior interaction with health authorities such FDA, EMA, PMDA, ICH, USP)
- Statistical design and analysis supporting the Biologics Manufacturing Process (Process Development (QbD principles, Process Characterization), Process Validation (CQA assessment, PPQ acceptance criteria), Process Monitoring (PAT, SPC, CPV))
- Statistical design and analysis supporting Analytical Methods (Analytical Method Development, Analytical Method Qualification and Validation, Analytical Method Comparability and Transfer, Analytical Method Performance Monitoring)
- Statistical data analysis for long-term / accelerated stability studies and shelf-life determination
- Statistical analysis supporting product specification
Preferred / Additional Qualifications:
- An advanced degree in a quantitative discipline
- 4+ years of experience as a Non-clinical / CMC Statistician supporting commercialization in a Biologics / Biotech environment
- Prior experience with data-driven Root Cause Investigations (Data-mining / machine learning techniques, FMEA)
- Multivariate analysis of process and analytical data (using tools such as SIMCA, PLS_Toolbox)
- Data Visualization
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.
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