Johnson & Johnson Careers


Irvine, California

Job Description

Requisition ID: 6503190204

The Johnson and Johnson Medical Device (MD) Sector Strategic Operations Group is recruiting for a Lead Biostatistician with primary location in Irvine, CA.  Other locations in Warsaw, IN, West Chester, PA, Somerville, NJ or Raynham, MA will also be considered.  This position may require up to 15% domestic travel.


The Lead Biostatistician will be primarily responsible for statistical support for compliance to EU Medical Device Regulation (MDR). The Lead Biostatistician will:


§  Collaborate with the Research Biostatistics group on providing statistical support for EU MDR.

§  Contribute statistical expertise as necessary to work with a cross-functional team working on the EU MDR requirements and reports to be submitted.

§  Perform analyses on data from registries.

§  Act as a statistical consultant to the business units and external customers and resolve statistical issues related to MDR and Post Market Surveillance (PMS).

§  Provide state-of-the-art statistical strategies to meet business objectives by offering technical direction and leadership.

§  Review protocols for proposed studies with respect to statistical methodology as needed.

§  Provide statistical support during discussions with regulatory agencies.

§  This is a project assignment, which is expected to conclude at or prior to 24 months from your start date in this project role. 


·       A minimum of a PhD with 1-year post doc of statistical analysis experience is preferred.

·       A minimum of 3 years in outcomes research in medical research.

·       Expertise in statistical methodologies applicable to post-market surveillance and registries is required.

·       Able to interpret and analyze clinical and post-market surveillance data.

·       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.

·       Strong proficiency in SAS or R is required.

·       Knowledge of Microsoft packages; PowerPoint, Excel, Word is also required.



Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All

qualified applicants will receive consideration for employment without regard to race,

color, religion, sex, sexual orientation, gender identity, age, national origin, or protected

veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-California-Irvine-
Depuy Orthopaedics. Inc. (6029)
Job Function
Requisition ID