Job Category: Clinical & Statistics

SENIOR DIRECTOR BIOSTATISTICS

Job Location: Tri-State Area

Location: Tri-State Area.

Reports to Vice President of Biostatistics. Therapeutic Area: Oncology. Oversee team of 10-12 Statisticians.


RESPONSIBILITIES:

Creation of clinical development plans (CDP), study design, and operational aspects. Represent statistics in key project decisions and regulatory meetings. Serve as departmental representative on corporate-wise teams. Review critical documents, such as SAP, Topline Results, CSR, and integrated summaries. Ensure compliance with data submission guidelines. Provide statistical support for US and EU regulatory submissions, inclusive of review of and contribution to clinical trial SAP and derived datasets to ensure that aspects of the SAP and derived datasets are able to be implemented from a programming aspect and that they are practical and feasible. Plan and track project activities, timelines, and resource use. Manage budgets to maximize the ROI of external vendors and limiting the out-of-scope work of external vendors. Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group.Participates in task forces and cross-functional operational excellence initiatives.


REQUIREMENTS:

10-12 Years of progressive responsibility in statistics roles with at least 6 years of people management experience. PhD in Biostatistics or Statistics from an accredited University. Demonstrated knowledge of statistical methods that apply to Phase II and Phase III clinical trials.Preferred to have interaction with FDA & other Health Authorities. Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice. SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery). Ability to manage multiple projects, set priorities and meet deadlines.Demonstrated ability to work effectively on a team n entrepreneurial environment.


Please contact Darren Gutowski at dgutowski@clarkdavis.com



Recruiter LinkedIn Page