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Manager, Biostatistics

  • Job type: Permanent
  • Location: Basking Ridge
  • Salary: $140000 - $170000 per annum, Benefits: complete benefits package + bonus
  • Job reference: MASL022318119
  • Sector: Biostatistics, EPM Scientific
  • Date posted: 23/02/2018
My client is a growing pharmaceutical company with a global presence. They are actively looking to build out their Biometrics group and are seeking two Managers of Biostatistics. 


This position would be responsible for methodological and statistical aspects of a project or group of clinical studies and will report to the designated TA lead. The Manager of Biostatistics will provide guidance to statistical matters to the clinical/regulatory team.


Responsibilities: 
  • provide guidance to a junior staff members
  • Provide leadership in development / design of one or more protocols for a specific project. 
  • Develop SAPs
  • Oversee execution of the statistical analysis according to the SAP and preparation of the statistical methods and results sections for the clinical study report (CSR).
  • Review submission documents, such as IND, BLA, or CTD to insure statistical validity and accuracy.
  • Collaborate with project team on the production of the clinical development plan (CDP).
  • Work with senior departmental staff to develop statistical position on key study or project issues. May act as representative to extended project team.
Requirements:
  • A PhD in Statistics or related discipline with 6+ years of experience in the biotechnology, pharmaceutical or health related industry.
  • Experience managing direct reports prefered
  • Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines
  • Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas/indicatioprexperience in design, production, and use of submission-quality electronic datasets
  • Ability to define and meet study / project timelines for deliverables such as protocol, clinical study summaries, and key analyses
  • Strong communication skills, experience managing internal team and CROs
  • SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)