Senior Scientist, Biostatistics Full-time

Senior Scientist, Biostatistics

Johnson & Johnson Innovative Medicine is recruiting for a Senior Scientist, Biostatistics to join the Statistics & Decision Sciences team. This position will be based at one of our office locations in either Spring House PA, Titusville NJ, Raritan NJ, San Diego, CA or Cambridge MA. (No remote option.)

The Senior Scientist supports the design and execution of studies and experiments for Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences programs at Johnson & Johnson Innovative Medicine (JJIM), with evolving 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 JJIM.

The position collaborates with Quantitative Sciences & Clinical Pharmacology (QSCP) functions and other drug development scientists. This role supports statistical aspects of key business and regulatory commitments, assists program plans, and represents Statistics & Decision Sciences (SDS) in various teams or working groups.

Key Responsibilities

Expertise:

• Exhibits effective proficiency in data analytics, grounded in statistical principles that lead to successful study support. Demonstrates competence in utilizing pertinent computational tools for research objectives related to studies, experiments, or trials, including full proficiency in R along with familiarity with other relevant computational tools, including innovative data-adaptive methods and artificial intelligence.
• Applies high-quality statistical methodology in assigned projects, showcasing an understanding of the disease/scientific/functional area and compliance with health authority standards. Acts with accountability, agility, and transparency. Exhibits knowledge of pharmaceutical research and development strategies and execution.
• Acquires and demonstrates knowledge for at least one disease area/target. Provides input in optimizing study designs to meet objectives, and supports scenario simulations and sample size calculations informed by technical and disease/scientific/functional area specific knowledge.
• Able to address complexities related to scientific, statistical, regulatory, operational, and partnership aspects. Progresses to more complex programs upon mastering standard ones.

Innovation:

• Implements advanced statistical techniques to address complex project or program features. Embraces opportunities of assessing and executing successful alternative or innovative approaches to statistical methodologies or business processes.
• Proactively provides input to team to help optimize study or trial designs in line with study or indication level objectives to enhance inferential insights while minimizing time, cost, and study risk.
• Strongly assists in problem-solving and troubleshooting at a program level, including regulatory and decision-making support. Collaborates cross-functionally to identify and resolve issues.
• Engages in process improvement and standards development initiatives.

Impact:

• Builds 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.
• Collaborates effectively with SDS colleagues and external partners to meet program needs. Represents Statistics & Decision Sciences in cross-functional and intra-departmental teams or working groups pertaining to scientific or process initiatives. Works within SDS and QSCP for unified and integrated quantitative input in drug development.
• Represents Statistics & Decision Sciences in cross-functional and intra-departmental teams or working groups pertaining to scientific or process initiatives. Delivers high-quality and timely deliverables as evaluated by stakeholders such as the project team, clinical trial team, and the Statistics Area Head. Holds responsibility and accountability for individual project execution, managing meetings with relevant project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
• Identifies vital external scientific and statistical trends, driving the advancement of statistical methodologies through scholarly publications. Engages actively in presentations at key forums and publishes work addressing business-related needs. Contributes as a member of professional organizations.

Key Behaviors:

• 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. Continuously grows global and big picture perspectives.
• 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.
• Takes responsibility and accountability for the quality and timeliness of project deliverables as assessed by stakeholders from respective projects or programs.
• 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, such as required training and project time accounting.
• Demonstrates understanding and alignment with pertinent regulatory guidance.
• Ensures that documents, programs, and all other deliverables are consistent and adhere to project and company standards.
• Supervises contractors, special assignment personnel, interns or co-ops as required.
• External: Contracted Partners and Suppliers, Regulatory Authorities, Key Opinion Leaders, Academia, Professional Societies, Public/Private Consortia
• The Senior Scientist practices J&J leadership principles and values aligned with the company's Credo and purpose.

Education and Experience

• Ph.D. in Statistics or related field with relevant experience, or Master's in Statistics or related field with commensurate years of relevant experience.
• Proficient in SAS and R programming, and other relevant computing tools (e.g., Python).
• Excellent interpersonal, verbal, and written communication skills in the English language.
• Demonstrated ability to work in interdisciplinary contexts outside statistics.
• Travel (domestic or international) anticipated to be <10%.

Experience Requirements

• Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories.
• Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers.
• Provides input to product development and performs statistical functions for submission related activities where appropriate.
• Ensures application of appropriate statistical methods and generation of accurate and reproducible results.
• Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
• Supervises contractors/special assignment personnel/interns/co-ops as required.
• Provides direct, hands-on experimental design, analysis, interpretation and statistical communications support.
• Prepares for 1:1 direct report-manager meetings.
• Uses R as primary programming language for modeling and evaluation, with demonstrated proficiency for visualization, document authoring, data wrangling, and modeling.
• Prepares and Demonstrates Proficiency and Etiquette for Virtual Meetings, especially when leading them.
• Assumes independent, professional responsibility and accountability for all end-to-end phases of a project request from beginning through completion, with minimal supervision as needed.
• Reads, Understands, and follows Instructions to meet Deadlines with complete content for Business Process and Compliance Needs including Training, Job Description/Curriculum Vitae for Job Readiness, Goals & Objectives, Mid-Year and End-of-Year Performance Evaluations.
• Efficiently self-manages multiple projects end-to-end with timely completions from initial consultation to documentation.
• Effectively navigates the tradeoff between quality and speed as equally important, ensuring one is not extremely favored at the expense of the other.
• Skillfully Responds to and Delivers Solutions for Urgent Health Authority Requests with sufficient prioritization.
• Accepts and Learns from Failures with a Professional, “Not-Yet” Growth Mindset. Complements this with a We will Figure it Out mindset to problem solve.
• Continuously Self-Learns and strives for self-improvement through digital channels of online courses, articles, software, literature, including GPT and related AI tools. Emphasize learning through doing and studying. Openness to Modern Models and Methods, Statistical and Computational.