Director / Senior Director, Biostatistics

Description

Job Overview: The Director/Sr. Director of Biostatistics will be a key member of the Biometrics function and is responsible for working with study team members to design protocols, develop and write statistical analysis plans, and perform statistical analyses for interim and final reports to be submitted to regulatory agencies. In addition to the oversight on Biostatistics counterpart from vendors, he/she will provide key biostatistical input and quantitative deep thinking to support projects in clinical development. The Director of Biostatistics will closely collaborate with partner functions such as Medical, Clinical Science, Clinical Operation, Data Management, and Statistical Programming. This position reports to the VP, Statistics and Quantitative Sciences (SQS). This will be a hands-on position with CRO oversight and the opportunity to grow your team.

 Responsibilities:

• Serve as a lead statistician and manage statistical efforts for one or more studies which could be pivotal studies.
• Manages and provides oversight of CROs statistical and programming support for outsourced statistical activities as well as QC key results generated by CROs.
• Collaborates with Data Management, Clinical and Clinical Operations on CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
• Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents.
• Collaborates with Statistical Programmers on summary and analysis of trial data.
• Contributes to clinical study reports and other regulatory documents (e.g., DSURs, Briefing Documents, etc.).
• Ensure accuracy, precision, efficiency, robustness in statistical planning, study design, statistical analysis, interpretation, reporting, and presentation of clinical study results
• Evaluate and interpret clinical trial data, write up reports, prepare slides and present results to internal and external stakeholders including regulatory agencies
• Take an active role in task forces or process-improvement groups and assist in providing guidance related to biostatistics, programming, and data management
• Support the preparation of publications, including manuscripts, abstracts, posters and oral presentations.

Requirements

Qualifications:

• Ph.D. in Biostatistics or Statistics or Equivalent with at least 6 - 8 years, or MS with at least 8 - 12 years, of experience in pharma or biotech industry
• Experience as lead statistician for a compound.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Proficiency in SAS Programming and other statistical software including EAST, nQuery and R.
• Experience with CDISC, including SDTM, ADaM, CDASH.
• Prior experience with IND/BLA/NDA/MAA submissions.
• Experience in writing technical and management documents, reports and presentations.
• Rare disease experience (preferred)