Scientific Director, Medical Affairs Biostatistics
Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring a Director, Medical Affairs Biostatistics to be located in Titusville, NJ or Raritan, NJ and may require up to 10% travel.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
In this position you will supporting Medical Affairs in the Oncology therapeutic area, you will provide critical statistical oversight to Medical Affairs clinical studies and will assume a leadership role in clinical trial and/or patient registries planning (mostly Phase 3b/4 trials or observational studies for post marketing commitments/requirements) and reporting related activities. You will also assume the role of a Statistics representative for cross-functional teams and work on several trials (projects) simultaneously.
- Provide statistical input for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support.
- Contribute/lead clinical study design, analysis planning and for the development of statistical analysis plan (SAP) and data presentation plan (DPS) for MA studies.
- Provide input to product development and performs statistical functions for submission related activities. Provide statistical support to other disciplines related to clinical statistics (e.g., HECOR/Epidemiology and publication activities).
- Serve as a primary contact with outside investigators (and vendors) in the preparation of scientic presentations and manuscripts.
- Interact with external Key Opinion Leaders (KOLs).
- Pursue rigorous statistical analyses in support of business-critical new research ideas.
- Explore and implements innovative statistical methods.
- Represent department in meetings with regulatory agencies.
- Ph.D. in Statistics or related field with a minimum of 8 years relevant experience .
- Experience working in Medical Affairs Statistics is preferred
- Experience in the area of Oncology clinical research is required .
- Experience in other therapeutic areas such as; Infectious Diseases and Vaccines and Immunology is desirable.
- In-depth working knowledge of statistical software such as SAS, R, is required.
- Intermediate to advanced proficiency level in applied biostatistical methodology with emphasis on pharmaceuticals is required.
- Demonstrated experience as an individual contributor is required while managing workflow in a crossfunctional matrix organization is preferred.
- Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is required.
- Excellent verbal and written communication skills, including formal presentation skills is required.
- Experience presenting to technical and lay groups at public meetings is required.
- Written skills as evidenced by publication and journal articles is preferred.
- Ability to successfully multi-task and work independently, under minimal supervision; excellent teamwork skills are required.
- Ability to influence, negotiate and communicate with both internal and external customers is required