HireDiversity

Raynham, MA, US

Biostatistician - Post Market Surveillance-7540121019

Description

DePuy Synthes a member of the Johnson & Johnson Family of Companies is recruiting for a Biostatistician to be located in Raynham, MA or West Chester, PA.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The Biostatistician will be responsible for designing statistical analysis plans for non-regulated studies. This role will perform statistical analyses under limited supervision. He/she will be contributing to reports intended for internal distribution and for regulatory submissions and creating internal presentations. The incumbent will supports statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts and quality initiatives.

This role will perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. The incumbent will know, understands, incorporates and complies with all applicable laws and regulations relating to DePuy's business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. He/she will write statistical analysis plans and system programming plans for all phases of clinical studies. This person will support moderately complex activities of clinical study design related to the implementation of a clinical study. The Biostatistician will format reports on the findings of statistical analyses and publications in preparation of new product applications to regulatory agencies. He/she will design and executes statistical plans under limited supervision.

This person will produce statistical reports that may be incorporated into internal clinical reports, or regulatory submissions. He/she may contribute to peer reviewed articles under supervision. The incumbent will review articles on subjects relevant to DePuy and provide reports concerning issues relating to statistical methodology; reviews protocols for proposed studies with respect to statistical methodology. He/she will assist with preparation of documentation for IRB/Ethics Committee submissions (e.g. statistical power analysis). This role will assist senior staff with the preparation and documentation of facts to write and support trial reports and publications. The Biostatistician will document and maintain important information on data management, and registry reports. This role will resolves basic statistical issues from the business units and external customers.

Qualifications


A minimum of a Bachelors degree with a least 4 years experience in performing statistical analyses in a regulated environment or Masters Degree with at least 2 years experience in performing statistical analyses in a regulated environment or a PhD with 0-2 years in relevant experience. Industry experience in Medical Device and/or Pharmaceutical is preferred. Knowledge and/or experience with the FDA, ICH and/or GCP is preferred. Knowledge of experimental design, thorough understanding of descriptive statistics is required. An understanding of hypothesis testing, non-parametric and multivariate statistical tests is required. The ability to manage multiple objectives from diverse stakeholders with limited supervision is required. Must have the ability to make judgments regarding the selection of statistical tests to be performed, and how to present data. Basic epidemiological methodology is preferred. The ability to be methodical and analytical and have an eye for detail is required. This person must have the ability to interact cross functionally and have excellent communication skills. This role may require up to 10% travel and be based in Raynham, MA or West Chester, PA

Primary Location:North America-United States-Massachusetts-Raynham
Other Locations:North America-United States-Pennsylvania-West Chester
Organization: DePuy Synthes, LLC (6149)