Associate Director, Medical Affairs Biostatistics
Location:
Hopewell Township , New Jersey
Posted:
April 02, 2017
Reference:
0067170310/1-en-us

Janssen 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.

 

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.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

 

Supporting 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.

 

The 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 publication activities).
  • May serve as a primary contact with outside investigators (and vendors) in the preparation of scientific presentations and manuscripts. 
  • May interact with external Key Opinion Leaders (KOLs).
  • Pursues rigorous statistical analyses in support of business-critical new research ideas.
  • Explores and implements innovative statistical methods. 
  • Represents department in meetings with regulatory agencies.



Qualifications
  • 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 required. 
  • 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 required.
  • Ability to influence, negotiate and communicate with both internal and external customers is required
  • This position will be located in Titusville, NJ or Raritan, NJ and will require up to 10% travel


Primary Location
United States-New Jersey-Titusville
Other Locations
North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Biostatistics
Requisition ID
0067170310

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