Job Description

Principal Biostatistician
full-time
onsite 3 days/week in Malvern, PA

SUMMARY
This Principal Biostatistician will work with Biometrics Director to manage one or more compounds/Indications in R&D for the entire life cycle. He/she will be responsible for all statistical aspects of the drug development and/or post-approval programs. These responsibilities include Regulatory interactions, study design, statistical methodology, analysis, regulatory submission, and/or pre- and post-approval activities. He/she will coordinate statistical and programming support and will manage contractors/CROs when necessary. He/she will also serve as lead statistician for clinical studies and work with the study team members effectively.

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 Affair, 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).
-Capability in working independently and lead one or multiple clinical studies
-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.

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