Director Biostats Real World Evidence

Bristol Myers Squibb-posted 2 days ago
$218,740 - $265,060/Yr
Full-time • Director
Madison, WI
5,001-10,000 employees
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The RWE Director is a key member of cross-functional teams and RWE-CoE within GBDS. This role will be responsible for developing the strategic direction and leading execution of statistical and real-world evidence studies and initiatives. This key position involves providing expertise in statistical methodologies, study design using real-world data to facilitate and support development and regulatory interactions of pharmaceutical products. This position is also responsible of performing the curation, transformation, and analysis of complex healthcare datasets to inform evidence generation, supporting developing clinical program design, clinical trial execution, and other data-driven decision-making activities. The ideal candidate will have deep expertise in working with RWD (e.g., claims, EMR, registries), RWE and clinical trials experience, advanced RWD/causal inference methodologies, strong analytical and communication capabilities, and a collaborative mindset.

  • Independently leads, initiates, and oversees the statistical support of RWE studies, including the development of methodologies, data analysis, interpretation, and reporting of study results
  • Independently lead curation and assessment of the quality of RWD assets to ensure their suitability and understanding for intended use.
  • Lead the design and implementation of data pipelines to transform raw RWD into datasets ready for analysis.
  • Lead and oversee exploratory data analyses, identify patient cohorts, and perform data summary analytics to support real-world evidence (RWE) generation.
  • Continually expand technical knowledge of statistical considerations in real-world evidence generation to ensure high-quality study design and analysis.
  • Collaborate with cross-functional teams—including TA-Biostatistics, Data Science, HEOR, Epidemiology/Safety, Clinical, and IT—to define data requirements and analytical strategies.
  • Ensure all work complies with data governance, privacy, and regulatory standards.
  • Stay up to date with industry and regulatory trends, tools, and best practices in RWD/RWE analytics.
  • Enhance understanding of the drug development process, as well as regulatory and commercial requirements.
  • Represents BMS at professional societies, and in industry-wide technical discussions.
  • Contributes to the statistical community of practice.
  • Provides active coaching to RWE team members when developing solutions to problems.
  • Enables a culture of inclusiveness, respect for diversity, and compliance with process
  • PhD (9+ years’ experience) or MS (11+ years’ experience) Epidemiology, Biostatistics, Data Science, Health Informatics, or a related field.
  • 3+ years of experience working with real-world healthcare data (claims, EMR, registries, etc.).
  • 6+ years of experience in pharmaceutical industry (e.g. Pharma, CRO, Biotech) and clinical trials.
  • Proficiency in SAS, R, Python, or similar tools for data manipulation and analysis.
  • Extensive experience with RWD data curation, engineering, exploration, and quality control in large-scale datasets.
  • Extensive RWD trial design and analysis experience
  • Good understanding of industry RWD vendor database.
  • Experience in preparing and participating in global regulatory agency interactions.
  • Ability to communicate complex real-world data concepts to non-technical stakeholders.
  • Ability to work successfully within cross-functional teams
  • Ability to organize multiple work assignments and establish priorities
  • Strong understanding of healthcare industry regulatory compliant data standards.
  • AI/ML knowledge is a plus.
  • 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.
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.
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