Director Biostats Real World Evidence

Bristol Myers Squibb•Madison, WI

About The Position

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.

Requirements

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.

Nice To Haves

AI/ML knowledge is a plus.

Responsibilities

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

Benefits

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.
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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