Job Title: 

Department: 

Description: 

The primary purpose of the Senior Biostatistician is to provide overall management, structure, and leadership for the biostatistics, programming and clinical data management (BPDM) functions, with focus on Good Clinical Practices. 

Job Responsibilities:

• Contributes as a member of the Clinical Research and Development management team and Project Teams and serves as an internal resource to provide technical expertise for management, scientists, and other technical professionals.
• Manages the design, development, selection, implementation, and maintenance of in-house BPDM capabilities.
• Evaluates and implements systems and standards, which includes generating validated output for clinical study reports, investigator brochures, manuscripts, and other documents for submission to regulatory agencies.
• Manages CROs and other vendors.
• Performs secure and accurate data transfers, and conducts application development to support BPDM activities at Targacept.
• Provides BPDM timelines, assigns BPDM tasks, provides necessary BPDM project materials to the appropriate individuals, and assists project teams to establish project-specific procedures.
• Develops and applies BPDM tools integrated with an informatics database strategy, which includes incorporation of large databases for collaborations, strategic alliances, and research efforts, while developing/maintaining applications systems for management/data analysis.
• Ensures compliance with 21CFR Part11 and all other relevant regulations and guidelines for BPDM activities.
  Prepares project summaries/reports and reviews BPDM status on regular basis.
• Implements and oversees program standards/processes related to the construction of statistical analysis files, case report tabulations, tabular/graphical summaries, and data structures of external primary/secondary sources.
• Develops and ensures validity of proposed methods and statistical integrity for design of data management plans, statistical analysis plans, protocols, and reports.
• Meets with outside vendors: negotiates proposals for use of data management equipment and systems.
  Trains and mentors BPDM staff, as required.
• Assists with the creation, maintenance, and utilization of Standard Operating Procedures documentation.

Reports to:  Director, Clinical Operations

Requirements: 

This position requires an advanced degree in Statistics, Biostatistics, or equivalent (Ph.D. and 5 years of experience or a Master’s Degree and 7 years of experience in biostatistics and clinical data management within the pharmaceutical or biotechnology industry.  Experience must include at least 3 years of “big pharma” experience (with an additional 3 years of management experience).  Candidates who have transitioned from big pharma to biotech are preferred.  Technical expertise in biostatistics, SAS programming, clinical data management systems/procedures especially electronic data capture, as well as a strong knowledge of the applicable regulatory requirements for these functions is essential.  Must have a working knowledge of clinical research processes, trial designs, development of protocols/analysis plans, database management, and FDA/EMEA regulations and guidelines.  Must have the capability to discuss statistical aspects of studies with investigators, medical directors, and regulatory authorities, and possess skills and knowledge for project planning/management/control, budget management, etc.  Experience in CNS strongly preferred.

Excellent project management skills and strong oral and written communication skills are required.  This person must be capable of working in a team-oriented and rapidly changing environment.  Must maintain comprehensive proficiencies with Microsoft Office and associated modules.

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