HireDiversity

Raynham, MA, US

Staff Biostatistician - Post Market Surveillance-7524121019

Description

DePuy Synthes a member of the Johnson & Johnson Family of Companies is recruiting for a Staff Biostatistician - Post Market Surveillance to be located in Raynham, MA or Westchester, 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 primary role for this Staff Biostatistician will be to lead the statistical and analytical services in support of the post-market safety surveillance of company products. In addition, he/she may provide statistical and analytic support for clinical trials, regulatory submissions, marketing efforts, and quality initiatives. He/she will provide guidance on standards and processes and/or technical direction within the statistics team. This role will be responsible for developing strategy and designing statistical analysis plans for regulated and non-regulated studies. He/she will perform statistical analyses independently; create reports intended for internal distribution and for regulatory submissions. This person will create internal presentations and white papers, and may interface with surgeons to assist in drafting peer reviewed journal articles.

The Staff Biostatistician 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, understand, incorporate and comply 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 assist in the development and execution of statistical methods in a company-wide product safety surveillance. He/she will assist in developing strategy for clinical trials. This role will design and execute statistical plans independently, assumes a leadership role in creating strategy for clinical research analyses. This person will review regulated and non regulated clinical protocols. He/she will produce statistical reports that may be incorporated into internal clinical reports, or regulatory submissions and may supervise others engaged in this activity.

The incumbent will contribute to and coauthors peer reviewed articles independently in coordination with the lead author/physician. He/she will review articles on subjects relevant to DePuy and provides reports concerning issues relating to statistical methodology as well as review protocols for proposed studies with respect to statistical methodology. This role will assist with preparation of documentation for IRB/Ethics Committee submissions (e.g. statistical power analysis). The Staff Biostatistician will act as a statistical consultant to the business units and external customers on statistical issues. He/she will interpret statistical analyses and publications in preparation of new applications to regulatory bodies. This role will write and support trial reports and publications. This person will oversee the work of outside agencies in statistical projects and programming endeavors. This position will provide state-of-the-art statistical strategies to meet business objectives by offering technical direction and leadership. He/she will audit statistical analyses completed by lower level biostatisticians and recommends review and/or corrective action.

Qualifications


A minimum of a Masters degree with at least 6 years experience in performing statistical analyses or a PhD with 4 years of performing statistical analyses is required. Experience in Medical Device and/or Pharmaceutical industry is required. This role must have knowledge and interaction with the FDA, ICH and GCP. Experience with data mining a plus. A strong knowledge of products/therapeutic areas being evaluated is required. Knowledge of experimental design and thorough understanding of descriptive statistics is required. An understanding of hypothesis testing, non-parametric and multivariate statistical tests is required. Knowledge of Bayesian statistics and meta-analyses is preferred. A thorough understanding of covariate analyses is required. The ability to manage multiple objectives from diverse stakeholders without supervision is required. Basic epidemiological methodology is preferred. Familiarity with other statistical packages for handling smaller datasets and power analyses is a plus. The ability to make judgments regarding the selection of statistical tests to be performed, and how to present data is required. This role must have the ability to assist in selecting and defining independent and dependent variables in the field of application and contribute to strategic planning. Experience leading and or supervising junior staff is a plus. The Staff Biostatistician will require up to 10% travel. The role will be based in Raynham, MA or West Chester, PA.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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