The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Senior Research Biostatistician with primary location in Irvine, CA. Other locations such as Warsaw, IN, West Chester, PA, Somerville, NJ or Raynham, MA will also be considered.
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 (5Ps) 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 Senior Research Biostatistician will be responsible for applying innovative statistical methodologies primarily for non-clinical research and in clinical research as needed within the Medical Devices Sector.
In addition, the Senior Research Biostatistician will: Qualifications
• Collaborate with the Biostatistics group and provide statistical support for research and development, quality initiatives, and complex clinical trial research as needed as well as provide guidance on standards, processes, and other technical topics.
• Act as a statistical consultant to the business units and external customers on statistical issues related to clinical and non-clinical research.
• Provide state-of-the-art statistical strategies to meet business objectives by offering technical direction and leadership.
• Resolve complex statistical issues from the business units and external customers.
• Review protocols for proposed studies and IIS proposals with respect to statistical methodology as needed.
• Provide statistical support during discussions with regulatory agencies.
• Contribute to and co-author peer-reviewed articles independently and/or in coordination with the lead author/physician.
• A minimum of a PhD with 1 year post doc of statistical analysis experience is required.
• A minimum of 3 years in a medically-related position that includes FDA, GCP or relevant area is also required.
• Expertise in statistical methodologies in preclinical, clinical, and non-clinical settings is required.
• Experience with survival analysis, optimal experimental design, Bayesian methods and adaptive designs is strongly preferred
• Ability to work independently in addressing research requirements is required.
• Ability to make judgments regarding the selection of statistical tests to be performed, and how to present data is also required.
• Knowledge of products/therapeutic areas being evaluated including at least one of the following: orthopedics, gynecology, cardiovascular or general surgery is preferred.
• Ability to work effectively within a cross-functional team is required.
• Experience working with SAS and R is required
• Knowledge of Microsoft packages; PowerPoint, Excel, Word is also required
• Job requires travel, up to 15%Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function