Principal Scientist, Biostatistics
About The Position
The Principal Scientist provides input to the design and execution of studies and experiments for Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences programs at J&J Innovative Medicines (J&J IM), with minimal supervision. Support is provided to statistical analysis, interpretation, and reporting or communication of data evidence towards programs for research, development, and/or marketed product needs in J&J IM. This individual will collaborate with Quantitative Sciences & Clinical Pharmacology (QSCP) functions and other drug development scientists to support statistical aspects of key business and regulatory commitments, contributes to program plans, and represents Statistics & Decision Sciences (SDS) in various teams or working groups. They will practice J&J leadership principles and values aligned with the company’s Credo and purpose.
Requirements
- A minimum of a Master's degree with 6+ years of relevant experience, or a PhD with 4+ years of relevant experience is required.
- Proficiency in SAS, R programming or other relevant computational tools (e.g., East Horizon, RPACT, FACTS, Python) are required.
- Excellent interpersonal, verbal, and written communication skills are required.
- Demonstrated ability to work in interdisciplinary contexts outside statistics is required.
Responsibilities
- Exhibiting advanced proficiency in data analytics, grounded in statistical principles with a proven record of effectively supporting programs.
- Demonstrating competence in using pertinent computational tools for research objectives related to studies, experiments, or trials, including full proficiency in R and SAS, along with familiarity with other relevant computational tools, including innovative data-adaptive methods and artificial intelligence.
- Ensuring the application of high-quality statistical methodologies in assigned projects, showcasing an understanding of the disease/scientific/functional area and compliance with health authority standards.
- Integrating quantitative sciences with disease or functional area requirements, balancing scientific and business needs.
- Providing leadership in optimizing study designs to meet objectives, and supports scenario simulations and sample size calculations informed by technical and area specific knowledge.
- Proactively identifying complexities related to scientific, statistical, regulatory, operational, and partnership aspects.
- Progresses to more complex programs upon mastering standard ones.
- Identifying and implementing advanced statistical techniques to address complex project or program features.
- Serving as a recognized leader, offering guidance to the team on optimizing study or trial designs in accordance with study or indication level objectives.
- Improving inferential insights while minimizing time, cost, and study risk.
- Collaborating cross-functionally to identify and resolve issues.
- Engaging in process improvement and standards development initiatives.
- Building cross-functional partnerships with internal colleagues and external partners (e.g., Contract Research Organizations (CROs), consultants) to achieve results for project-specific needs, focusing on enhancing communication, efficiency, and productivity.
- Working within SDS and QSCP for unified and integrated quantitative input in drug development.
- Delivering high-quality and timely outputs as evaluated by partners such as the project team, clinical trial team, and the Statistics Area Head.
- Identifying vital external scientific and statistical trends, driving the advancement of statistical methodologies through scholarly publications.
- Participating in interactions with health authorities.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (may vary by state)
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Principal
