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Senior Director, Biostatistics

Date: Jun 11, 2021

Location: US US GB

Company: Cytel Inc

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

 

The Senior Director of Biostatistics provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. Responsibilities include: providing statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data); communicating with clients regarding study protocol or statistical analysis issues; and writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.

 

The Senior Director of Biostatistics analyzes clinical trial data producing accurate results representing the outcome of the trial, validates statistical output, accurately interprets and clearly communicates statistical results and concepts to non-statisticians. With the medical writer, co-authors final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report. The Senior Director of Biostatistics also provides statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

 

The Senior Director of Biostatistics provides input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participates in interactions with regulatory agencies, as required. In addition, the Senior Director of Biostatistics collaborates effectively with members (internal and external) of clinical trial implementation teams and with Biometrics colleagues, and keeps abreast of new developments in statistics, drug development, and regulatory guidance.

 

The Senior Director of Biostatistics is the key client interface for all statistical issues and discussions.  Leads the cross functional internal team members to ensure that project work is completed on time, on budget, and with high quality.  Communicates to Project Manager and SVP, Clinical Research Services on key client and project issues that require change of scope for the project and/or management of client relationships.  Participates with the preparation of client proposals including presenting at business development meetings with potential and current clients.  Present at industry conferences representing Cytel and assisting with the Business Development activities at key conferences and industry meetings. Leads or participates as a key member of process improvement initiatives.


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