Principal Biostatistician Consultant- Hybrid (NJ/PA/DE)

ClinChoice

1d•Hybrid

About The Position

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for an Principal Biostatistician Consultant to join one of our clients. Hybrid in any of these locations NJ/PA/DE ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. JOB SUMMARY: This contract principal statistician 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.

Requirements

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.
Ability dealing with ambiguity.
Ability to handling stress.
Drive for results.
Ability to prioritize.
Ability to establish and maintain effective working relationships with team members, managers, and partners.

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).