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. Associate Director, USMA Real World Evidence Epidemiologist
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Summary/Scope:
The Real-World Evidence (RWE) Epidemiologist oversees USMA Hematology Registry study conduct from an epidemiology perspective as well as oversees and/or conducts high-quality statistical analyses of Registry data or other real-world databases to address open data questions to support Bristol-Myers Squibb (BMS) US Medical Affairs (USMA) Disease Teams, including Integrated Evidence Plans, Registry publication plans and/or cross-functional internal and external RWE collaborations in a timely manner and in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
Responsibilities include, but are not limited to, the following:
Location, Knowledge, Experience, Skills
- Provides expert epidemiologic guidance, direction, and execution of Registry study conduct in collaboration with Operations (GDO) and Medical Team.
- Provides and clearly communicates, verbally and written, analytical and methodological expertise on RWE studies within Medical Affairs, cross-functionally and to external stakeholders.
- Can independently conduct comparative safety and effectiveness analyses, when needed, in a variety of real-world data sources.
- Provides observational data analyses oversight in collaboration with other analytical teams, including Biostatistics and HEOR, where needed, to support timely, targeted and accurate reporting and outcomes from assigned Registries and other RWE projects.
- Partners closely with and seeks input from Disease Teams and Steering Committee members to ensure clear direction and alignment internally and externally of Registry study objectives, analyses and publications.
- Seeks extensive collaboration and cross-functional input on RWE analyses conduct and interpretation.
- Has experience working with CROs, particularly real-world data providers and analytics service providers, and can evaluate vendor products for feasibility and applicability to in-house analytic needs.
- Provides input to the design of case report forms and/or RWE database, if applicable, for proper data capture and to ensure data quality.
- Develops high-quality, comprehensive study proposals or protocols containing clearly defined patient populations, study objectives, and study design that can be readily and correctly implemented.
- Collaborates with others and/or guides others in measurement and monitoring of study progress against objectives and plans, including any variances. Includes proactively guiding other team members on identifying, communicating and addressing any issues, challenges and potential strategies to resolve such.
- Maintains the highest standards and levels of scientific/clinical and epidemiologic knowledge in the specific therapeutic and disease area(s) of assignment.
- Stays current on pharmacoepidemiologic and statistical methods.
- Position based in Summit, NJ, preferred
- Requires excellent communication and negotiation skills with an ability to efficiently and productively communicate both orally and in writing
- Ability to work independently and collaboratively, and drive consensus across cross-functional teams
- A demonstrated excellence in project management and effectively managing multiple projects/priorities is required
- Drives for high-quality results and demonstrates analytical mindset
Minimum Basic Qualifications :
- PhD, ScD, DS, or MPH in Epidemiology, preferably Pharmacoepidemiology
- A minimum of 5 years' experience in independently conducting analyses and statistical programming of clinical observational data, including registry and/or electronic health record data (SAS programming preferred)
- Demonstrated experience in comparative effectiveness research, preferably in oncology or hematology
- A minimum of 3 years' experience as a Study Epidemiologist on a patient registry study preferred
- Experience working in the pharmaceutical industry, particularly in areas of oncology or hematology preferred
- Collaborates with colleagues within Medical Affairs and from other Departments to maximize efficiencies, share and apply best practices.
- Stays current on advanced analytics training, including mining and linking large observational databases as well as knowledge of integrated database systems and data warehouses.
- Flags potential process improvement opportunities and supports execution.
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.