Welcome to Professional Resources, Inc.
Submit Your Resume View All Jobs

Title:Manager, Biostatistics
Salary:Open
Experience:2-6
Location:CA - Foster City

Description:
Create statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis).

Responsibilities:
  • Provides statistical consultation on trial design and study endpoints
  • Create statistical analysis plans
  • Create templates for tables, listings and graphs
  • Review and approve dataset specifications
  • Review and approve key study related documents produced by other functions (e.g. CRFs, Data Management Plans etc)
  • Works on 4-6 clinical trials / projects as well as other tasks as assigned by supervisor
  • Participate in the finalization of protocol deviations and analysis sets
  • Create statistical reports
  • Create statistical text for CSRs, clinical publications and other communications
  • Plan and execute statistical review and QC of CSRs, clinical publications and other communications
  • Plan and execute statistical review and QC of ISS/ISE
  • Oversee the work of outsourcing partners and vendors at the product level
  • Create Requests for Proposals (RFPs) from outsourcing vendors for statistical services
  • Contribute to decisions on selection of outsourcing partners and vendors-Lead and/or participate in the development and review of Company Policies, SOPs and other controlled documents
  • Participate in study and systems audits by CQA and external bodies, and respond to audit questions and findings
  • May manage and develop a small number of statistical staff
  • Participate in the recruitment of statistical staff
  • Provide input to and participate in intra-departmental and global Biostatistics meetings
  • Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
  • Promote and communicate statistical awareness and the role of the Biostatistics department (internal/external; scientific/process)
  • Contribute to the continuous improvement of Global Biostatistics.

Requirements:
  • Typically requires a BS degree in Biostatistics or equivalent and minimum 6 years of relevant industry experience, or a MS degree in Biostatistics or equivalent and minimum 4 years of relevant industry experience, or a PhD degree in Biostatistics or equivalent and minimum 2 years of relevant industry experience in the statistical analysis of biomedical data using SAS software.

Submit Your Resume View All Jobs