Senior Principal Scientist, Biostatistics

Expertise

• Exhibits advanced data analytics expertise through applied experience, grounded in statistical principles with a strong record of effectively supporting programs.
• Demonstrates proficiency in utilizing computational tools to analyze and visualize data for research objectives related to studies, experiments, or trials, including full proficiency in R and SAS and familiarity with innovative data-adaptive methods and artificial intelligence.
• Ensures 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.
• Applies statistical expertise in drug development to improve experimental design, modeling, analysis planning and execution, interpretation, and statistical communications.
• Demonstrates knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
• Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution.
• Proactively identifies and substantially helps solve complexities related to scientific, statistical, regulatory, operational, and partnership aspects.
• Applies advanced statistical methodology with demonstrated integrated disease/scientific/functional area understanding and regulatory acceptability to improve the probability of regulatory approval and product differentiation.
• Identifies and implements advanced statistical techniques to address complex project or program features.
• Serves as a recognized leader, offering guidance to the team on optimizing study or trial designs in accordance with study or indication level objectives.
• Proven ability in problem-solving and troubleshooting at the program level, including supporting strategic scenario planning, quantitative decision-making, and regulatory support.

Impact

• Demonstrates strong skills in building relationships across functions and has an influential voice in SDS, Global Development, and with TAs or Functional Areas.
• Is accountable as a point of contact for a specific project or program (e.g., Clinical Trial Statistical Lead) and the management of all related project/program deliverables.
• Collaborates effectively with SDS colleagues and external partners to meet program needs.
• Represents Statistics & Decision Sciences on various teams, senior management-level reviews, working groups, and health authority interactions.
• Builds cross-functional partnerships with internal colleagues and external partners (e.g., CROs, consultants) to achieve results for project-specific needs.
• Able to serve as SDS representative for internal Due Diligence activities.
• Identifies vital external scientific and statistical trends, driving the advancement of statistical methodologies through scholarly publications.
• Participates in interactions with health authorities and contributes actively as a member of professional organizations.
• Works with cross pharma consortiums to develop industry standards.
• Authors scientific journal manuscripts and peer reviews or edits manuscripts for professional journals.

Qualifications/Requirements

• Master's Degree in Statistics with 10+ years exp OR PhD in Statistics with 7+ years in related field of clinical data analysis experience, is required.
• Credo-based leadership consistent with J&J IM Leadership Imperatives to develop and persuasively deliver statistical strategy and scientific advice to development programs.
• Displays a proactive approach and cultivates a growth mindset for personal development.
• Keeps up-to-date with the changing landscapes in drug development and statistical methodology, and shows adaptability to optimize contributions to the J&J IM pipeline.
• Exhibits strong written, oral, and interpersonal communication skills, and demonstrates proficiency in collaborating with non-statisticians by translating intricate statistical concepts for drug research and development partners.
• Effectively communicates statistical findings to program stakeholders and broader non-technical audiences utilizing interactive graphical tools.
• Supervises contractors/special assignment personnel/interns/co-ops as required.
• Leverages experience to mentor emerging leaders in techniques, processes, and responsibilities.
• Takes responsibility and accountability for the quality and timeliness of project deliverables.
• Follows best practices for Good Clinical, Manufacturing, Laboratory, or other pertinent GxP activities and requirements, including Data Integrity.
• Complies with organization and company standard operating procedures in a timely fashion.
• Demonstrates understanding and alignment with pertinent regulatory guidance.