Job Category: Clinical & Statistics

Senior Manager, Biostatistics

Job Location: N/A

Assume responsibility for methodological and statistical aspects of a complex late phase study or group of clinical studies, with general direction. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams.

Responsibilities:
Support one or more clinical trial teams (CTT) for all relevant statistical matters. Act as direct liaison to the CTT or provide guidance to a junior staff member filling this role. Develop key protocols for a specific project. Work with clinical and regulatory functions to define study endpoints and perform relevant sample size calculations. Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC). Develop statistical analysis plan (SAP). Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. Collaborate with project team to create the clinical development plan (CDP). Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation. Provide technical guidance and mentoring to junior staff. Integrate corporate values into working practices.

Knowledge and Skills:
PH.D./MS in statistics or related discipline with 5-7+ years of pharmaceutical experience. Knowledge of pharmaceutical clinical development. Ability to use statistical methods to assess/improve efficiency and decision process in drug development. Expertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis. Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines. Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas / indications. Understanding of other functional areas and ability to maintain productive inter-function working relationships. Familiarity with design, production, and use of submission-quality electronic datasets. Ability to define and meet study / project timelines for deliverables such as protocol, clinical study summaries, and key analyses. Demonstrated high level of productivity and efficiency. Strong communication skills. Ability to organize, lead, and motivate teams.

Please contact Bill Emker at bemker@clarkdavis.com

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