Director of Biostatistics

Overall Job Description:

The Director of Biostatistics is responsible for providing scientific and statistical leadership for Cara’s clinical trials as well as for regulatory submissions, publications and posters.  For a given project, the incumbent acts as the Biometrics project leader coordinating all functions within Biometrics and is directly accountable for all statistical aspects of clinical studies and submissions, including quality and scientific validity. The Director of Biostatistics acts as Cara’s primary contact with Regulatory Authorities (ex: FDA, PMA) and Contract Research Organizations (CRO), representing the biostatistics function. The incumbent is also responsible for developing and maintaining standards and working practices for the biostatistical function. This position includes both a strategic and a “hands-on” component; it is expected that the Director of Biostatistics will provide statistical leadership and direct the work of CROs but will also execute planned or unplanned analyses as needed.  It is expected that the Director of Biostatistics will act with great deal of independence.

 

Primary Responsibilities:

  • Serves as the lead statistician for Cara’s projects, providing strategic and statistical input into all aspects of clinical development, including submissions to Regulatory authorities
  • Leads the effort in developing innovative trial designs that are aligned with the project strategy and that address statistical, medical, and/or operational issues
  • Reviews study protocols, develops or supervises the development of the statistical sections of protocols, the statistical analysis plans and the analysis specifications for the programming implementation of the statistical analyses
  • Provides statistical input into data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses
  • Develops statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provides statistical review of scientific reports and publications
  • Plans and track Biometric activities, timelines and resources for assigned projects and collaborates with other functional areas on overall project deliverables and timelines
  • Manages CROs within area of responsibility ensuring the quality, accuracy and timeliness of outsourced statistical deliverables
  • Evaluate resource needs within area of responsibility and provide timely feedback to supervisor regarding statistical deliverables
  • Adhere to the company SOPs and working practices; help develop SOPs relevant to the biostatistical function

 

Candidate Skills & Experience:

  • D. in Statistics or Biostatistics with 10+ years of experience in the pharmaceutical or biotech industry
  • Up-to-date expertise/knowledge in advanced statistical methodologies related to clinical trial design, statistical modeling and analysis
  • Knowledge of applicable ICH and FDA regulations
  • Experience with regulatory submissions to FDA (NDAs, sNDAs, preparation of ISS/ISE) and other regulatory agencies. Participation, as lead statistician, in regulatory meetings
  • Proficiency with the SAS programming language; knowledge of R or similar language a plus
  • Knowledge of CDISC standards, including ADaM requirements
  • Ability to build strong relationship with peers within the Biometrics department and cross functionally
  • Ability to work independently
  • Experience implementing successful working relationships and managing external vendors such as CRO, consultant groups, and research committees
  • Strong organizational and time management skills, and the ability to prioritize multiple deliverables and ad-hoc requests.
  • Excellent communication skills
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