What are the responsibilities and job description for the Principal Biostatistician position at Atorus?
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
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).
- 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.