Principal Biostatistician

Responsibilities

• Provide inputs to clinical team on the design, analysis and interpretation of scientific data from Phase I to IV clinical trials, ISS and ISE.
• Collaborate with the project team to design the protocols (synopses and full) and provide sample size calculations.
• Draft or review the SAP and the associated mock TLF.
• Performs review of TLFs to ensure that they are accurate within and across outputs for a particular deliverable (e.g., CSR, IDMC, publication).
• Provide statistical support for other functions within the organization (i.e., Medical Affairs, Regulatory, or others).
• Manage project timelines and interact with external vendors.
• Conduct DAR meeting prior to database lock or Comment resolution meeting.
• Prepare the presentations and interpret the results.
• Participate in data review meetings within the organization.
• Be Compliant with all trainings and SOPs.
• Contributes to intra- and interdepartmental process improvement activities to achieve “best practices”
• Mentor entry-level team member if needed.
• Manage internal and external employees/contractors.
• Continuously seek knowledge regarding most current statistical methods.
• Prepare presentations for internal and external audiences (presenting at key statistical meetings).

Qualifications

• M.S. or Ph.D. (or equivalent) in Statistics or Biostatistics is required.
• Minimum 4 years (Ph.D.) or 8 years (M.S.) pharmaceutical industry experience.
• Should possess experience interacting with regulatory agencies (e.g. FDA, MHRA or EMEA).
• Experience managing multiple projects/therapeutic areas.
• Experience in managing external vendors (e.g. contractors, CROs).
• Solid background of statistics.
• Experience of SAS, R and other statistical programming packages to validate key endpoint analysis.
• Possess extensive knowledge of the Drug Development Process.
• Possess extensive knowledge of regulatory policies and procedures.