Research & Development, LLC., a Johnson and Johnson Company is hiring an
Associate Director, Medical Affairs Biostatistics to be located in Titusville,
NJ or Raritan, NJ.
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
on a diverse company culture, celebrating the uniqueness of our employees and
committed to inclusion. Proud to be an equal opportunity employer.
Medical Affairs in the area of Oncology, the
Associate Director, Medical Affairs Biostatistics provides critical
statistical oversight to Medical Affairs clinical studies and assumes 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; assumes the role of
a Statistics representative for cross-functional teams and works on several
trials (projects) simultaneously.
Associate Director, Medical Affairs Biostatistics will:
- 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.
- Provides statistical support to other
disciplines related to clinical statistics (e.g., HECOR/Epidemiology and
- May serve as a primary contact with outside
investigators (and vendors) in the preparation of scientific presentations and
- May interact with external Key Opinion Leaders
- Pursues rigorous statistical analyses in
support of business-critical new research ideas.
- Explores and implements innovative statistical
- Represents department in meetings with
- Ph.D. in Statistics or related field with a minimum
of 6 years relevant experience OR a Master’s in Statistics (or related field)
with 8 years of relevant experience is required.
- Experience working in Medical Affairs
Statistics is preferred
- Experience in the area of Oncology clinical
research is preferred.
- In-depth working knowledge of statistical
software such as SAS, R, or related software is required.
- Intermediate to advanced proficiency level in
applied biostatistical methodology with emphasis on pharmaceuticals is
- Demonstrated experience as an individual
contributor is required while managing workflow in a cross-functional 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
- Ability to influence, negotiate and
communicate with both internal and external customers is required
position will be located in Titusville, NJ or Raritan, NJ and will require up
to 10% travel
United States-New Jersey-TitusvilleOther Locations
North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function