Director, Epidemiology

Johnson & Johnson•Horsham, PA

23h•Hybrid

About The Position

J&J is currently seeking a Director, Oncology Epidemiology. This is a hybrid role based in Raritan, NJ and Horsham, PA. Remote working options might be considered on a case-by-case basis. The Director, Oncology Epidemiology is accountable for working independently while functioning under the supervision of more senior members of Global Epidemiology. The Director, Oncology Epidemiology is responsible for oversight of various projects and initiatives in areas of epidemiology and real-world evidence research. This includes collaboration and stakeholder engagement with relevant clinical and product related and other RWE related teams, leading research projects, drafting protocols and statistical analysis plans, overseeing the analysis of real-world data (including, but not limited to, insurance claims data, hospital billing data, EMRs, curated oncology datasets, registries) and the dissemination of scientific information through technical reports, presentations, and publications in peer-reviewed literature.

Requirements

PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 6 years of hands-on experience is required.
At least 5 years of Epidemiology research experience is required.
Understanding and the ability to apply and interpret quantitative methods is required.
Experience writing observational study protocols, proposals, and proposal requests, particularly the methods sections is required.
Experience working with large administrative or medical records databases is required.
Background in the epidemiologic landscape of oncology including related conditions and therapies is required.
A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required.

Nice To Haves

Experience working with health authorities is preferred.
Product development experience in the pharmaceutical industry is preferred.
Experience working in a global, cross-functional team environment is preferred.

Responsibilities

Identify research study needs, drafting proposals and protocols, and contribute to real-world evidence (RWE) strategy and study conduct across the therapeutic area portfolio.
Work closely in collaboration with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, conducting analyses, and interpreting and communicating evidence to internal and external stakeholders.
Participate in various multi-disciplinary matrix teams to address issues raised by product teams/regulatory agencies where real-world data (RWD)/RWE can inform decisions.
Provide epidemiological and/or statistical consulting and support to compound/product teams, and disseminate technical information through reports, presentations, and publications in peer-reviewed literature as agreed by the team.
Work within and outside of existing electronic databases to: assess feasibility of fit-for-purpose RWD; research natural history of diseases to understand background event rates in the indicated population expected with standard of care; perform statistical risk assessments; use historical clinical trial data and other data sources to contextualize potential safety issues for new medications; support benefit-risk assessments throughout the product lifecycle; design and conduct post-authorization safety activities, including rapid analytics for signal strengthening and formal required/committed evaluation studies, as part of Pharmacovigilance and Risk Management Plans.
Be involved in supporting efforts for the Office of the Chief Medical Officer and cross-sector collaborations, as prioritized.
Promote the use of standardized tools to support real world evidence generation across functions utilizing RWE as part of the Integrated Evidence Generation Plan.
Keep up to date with changes in the external environment, including working through professional society and public-private consortia to advocate as a subject matter expert, regarding RWE guidance/framework for regulatory decision making.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year