Lead Biostatistician

The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Lead Biostatistician. The preferred location is Raynham MA, however we are also open to our West Chester, PA, or Warsaw, IN locations.

The MD CR&D COE is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies.  The COE organization is based on three functional teams: Franchise, Operations and Biostatistics & Data Management.  All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle.  Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination.

The Lead Biostatistician will be responsible for leading statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts, and quality initiatives, as well as providing guidance on standards, processes, and technical topics within the statistics team.  His/her work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post- market clinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Reporting to the Biostatistics Manager.

    • Provide guidance on standards, processes, and technical direction within the biostatistics team.
    • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
    • Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.
    • Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
    • Supervise generation of randomization schemes; supervise unblinding of treatment assignments and appropriate handling of unblinded information.
    • Lead the review and assessment of protocol deviations to the extent that they affect statistical analyses.
    • Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
    • Contribute to peer-reviewed articles independently, in coordination with the lead author/physician.
    • Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
    • Assist with preparation of documentation for IRB/Ethics Committee submissions.
    • Act as a statistical consultant to the business units and external customers on statistical issues.
    • Participate in vendor evaluation, selection, contracting, and oversight for statistical and programming deliverables.
    • Provide statistical reports for data quality/performance metrics.
    • Assist Clinical Research with literature reviews and other activities.
    • May assist in presenting information at professional meetings.
    • May oversee the statistical deliverables produced by lower-level biostatisticians or external consultants.
    • May oversee production of presentation materials for presentations at professional meetings.
    • Stay current with statistical methodology in clinical trial design and analysis.
    • Assist in the preparation and documentation of results to support trial reports and publications.

  • A Master’s degree in Statistics, Biostatistics, or Applied Statistics with at least 6 years of experience OR a Ph.D. with at least 4 years of experience performing statistical analyses in a regulated environment, preferably medically related is required.
  • Knowledge of US law, regulations, and FDA guidance covering good clinical practice (GCP) is required.
  • Demonstrated technical experience in preparing statistical deliverables on time is required.
  • Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, non-parametric, and multivariate statistical tests is required.
  • Ability to assist in selecting and applying statistical methods in the field of application is required.
  • Experience with survival analysis, longitudinal data analysis, and other current statistical methodologies is required.
  • Excellent verbal and written communication skills are required.
  • Proficiency in SAS and Microsoft software (Word, Excel, PowerPoint) is required.
  • Ability and willingness to travel up to 10% is required.
  • Familiarity with other statistical packages and power analysis software is required.
  • Knowledge of Bayesian statistics, meta-analyses, or simulation techniques is required.
  • Ability to contribute to strategic planning is preferred.

Primary Location
United States-Massachusetts-Raynham
Other Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-Warsaw
Depuy Orthopaedics. Inc. (6029)
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