Johnson & Johnson Careers

Associate Director, Statistical Modeling and Methodology

Raritan, New Jersey
Biostatistics


Job Description

Requisition ID: 7336190211

Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Associate Director, Statistical Modeling & Methodology 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. 


The  Associate Director of Statistical Modeling & Methodology is responsible for: identifying opportunities to utilize innovative designs and statistical analysis methods in drug development; proposing and developing innovative designs and analysis methods and evaluating them via simulation studies and other appropriate instruments; interacting with clinical teams to ensure the proper implementation of innovative approaches in clinical trials and development programs; participating in strategic planning and supporting the broad implementation of innovative approaches across clinical development; providing/arranging internal training on innovative designs and methods to ensure adequate knowledge and awareness of these approaches in the company; serving in internal Independent Data Monitoring Committees for trials involving innovative approaches requiring unblinded interim analyses; and maintaining external collaborations and interactions (via professional associations, participation in conferences, publications, etc) to influence the external pharmaceutical industry and regulatory environment.


  • Devise and implement strategy for promoting the broader utilization of innovative approaches across the development portfolio, through coordinated efforts involving clinical, operational, regulatory areas. Bring together key stakeholders from different key areas, identify potential hurdles for broader use of innovation in drug development and participate in finding solutions for them. Participate in resource planning for the Statistics and Decision Sciences (SDS) department and collaborate in talent identification, hiring and development. Ensure focus on innovation is maintained in SDS.
  • Propose, develop and implement innovative approaches: participate in hands-on implementation of innovative approaches, through direct interactions with clinical teams and other relevant groups. This involves, but is not limited to developing/identifying appropriate designs and methods; planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up. Engage external consultants and qualified CROs to provide support in the development and implementation of innovative methods, supervising them as needed. Participate in IDMCs for trials with unblinded interim analysis related to innovative approaches (e.g., adaptive designs), as needed.
  • Identify opportunities for innovation: participate in CDP reviews/discussions, interact directly with clinical teams and therapeutic area representatives for early identification of opportunities for innovative approaches. Assess feasibility and help establish prioritization of identified opportunities. Ensure implementation of selected opportunities, helping in the identification of responsible SMM representative.·       Devise and implement strategy for promoting the broader utilization of innovative approaches across the development portfolio, through coordinated efforts involving clinical, operational, regulatory areas. Bring together key stakeholders from different key areas, identify potential hurdles for broader use of innovation in drug development and participate in finding solutions for them. Participate in resource planning for the Statistics and Decision Sciences (SDS) department and collaborate in talent identification, hiring and development. Ensure focus on innovation is maintained in SDS.
  • Propose, develop and implement innovative approaches: participate in hands-on implementation of innovative approaches, through direct interactions with clinical teams and other relevant groups. This involves, but is not limited to developing/identifying appropriate designs and methods; planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up. Engage external consultants and qualified CROs to provide support in the development and implementation of innovative methods, supervising them as needed. Participate in IDMCs for trials with unblinded interim analysis related to innovative approaches (e.g., adaptive designs), as needed.
  • Identify opportunities for innovation: participate in CDP reviews/discussions, interact directly with clinical teams and therapeutic area representatives for early identification of opportunities for innovative approaches. Assess feasibility and help establish prioritization of identified opportunities. Ensure implementation of selected opportunities, helping in the identification of responsible SMM representative.
  • Ensuring proper knowledge and awareness of innovative methods and designs: identify, develop, organize, provide and/or arrange training and presentations on innovative approaches across the Development organization (including statisticians, modelers, clinicians, and other stakeholder groups) to ensure awareness and adequate knowledge about these methods. Keep up-to-date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model-based methods, etc.
  • External collaborations, visibility, and impact: engage in external collaborations within professional associations (e.g., DIA, PhRMA), leading and participating  in working groups, participating in program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals. Influence the pharmaceutical industry and regulatory environments, by engaging in scientific advocacy working groups and committees.
  • Carries out functional responsibilities in accordance with applicable SOPs/Guidelines and Regulatory requirements.
  • Assists in process improvement initiatives and SOP/Guideline development.



Qualifications

A PhD in Biostatistics or equivalent in Statistics or related field, with a minimum of 6 years of experience in drug development and/or applied quantitative methods for decision making, significant familiarity with scientific programming and simulation.

 

  • Sound knowledge of biostatistics applied to clinical trials and model-informed drug development.
  • Working knowledge of statistical modeling software, such as SAS, R, Win Bugs, or Matlab.
  • Experience with trial simulations to design and document adaptive trials and working knowledge of Bayesian methods. 
  • Stay current with the latest statistical methodologies with focus on trial optimization, simulation and adaptive designs.
  • Fluent in written and spoken English.

 

 

 

 

 


Primary Location
United States-New Jersey-Raritan-
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Biostatistics
Requisition ID
7336190211