Principle Biostatistician (DG)
Somerset County, NJ - Pharmaceutical & Biotech - Hybrid
Date Posted: 11/9/2022 10:02:19 AM
Somerset County, NJ (Hybrid 2/3 days)
Our client is looking for a Principle Biostatistician, who implements and executes methodological and statistical aspects of clinical studies with direction from Therapeutic Area lead biostatistician or project lead statistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases principal function could be to develop / employ technical expertise in a particular statistical area or application.
With periodic supervision and guidance from senior departmental staff, provide support and leadership to a clinical study team on all relevant statistical matters. Act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. With some supervision and guidance from senior departmental staff, design clinical study and help produce protocol or amendments. Perform relevant sample size calculations. Develop statistical analysis plan (SAP). Work with programming team to provide definitions, documentation, and review of derived variables needed to produce planned TFL. Perform statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR), and work with the study team to move the CSR through review and approval process. Provide statistical insight into interpretation and discussion of study results. Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities or independent monitoring committees. Provide assistance to project statistician or Therapeutic Area lead biostatistician in project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers. Active research interest in area related to clinical trial. Adheres to procedures surrounding retention of data, records, and information for clinical studies.
Requires a minimum of a Ph.D. in statistics or related discipline with 3+ (or MS and 5+) years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies. Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks. Works independently - self-directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required. Demonstrated strong leadership, project management, teamwork, and interpersonal skills. Excellent verbal, written & presentation skills. Broad knowledge and superior understanding of advanced statistical concepts and techniques. Experience with application of technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management. Familiarity and experience with regulatory guidelines for drug development, submissions, and statistical practices. Understanding of the drug submission and approval process regionally and globally. Proven ability to effectively represent Biostatistics and Data Management in multidisciplinary meetings. Experience managing direct reports, contractors, teams, and external agencies, such as CROs, consultant groups, and research committees. Proven ability to inspire and empower others. Sought out for advice by others at senior levels. Ability to work independently. SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery). May report to a Sr. Director or above. Requires the ability to influence others to achieve results. May manage subordinate supervisors. Level will be commensurate with experience.
Please contact Darren Gutowski at firstname.lastname@example.org