Director of Biostatistics Cytel Software
Department: Clinical Research Services
Reports to: Senior Director, Global Head of Biostatistics
Locations: 1. Waltham, MA, 2. Chesterbrook, PA
Cytel Inc. is a leading provider of clinical research services and trial design and analysis software/services primarily for the biopharmaceutical, medical device, academic and government researchers. All 25 leading global biopharma companies and over one thousand specialty developers, leading university and government-sponsored research centers use our technology in their clinical studies. Pioneers of the supporting statistical methods, every adaptive trial we've designed has been accepted by regulators. We're also increasing known for our cutting-edge clinical data handling techniques and management strategies.
The Director of Biostatistics provides statistical input into Phase 1 - 4 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 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 Director of Biostatistics also provides statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications.
The 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 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 through literature review and attendance at workshops and professional meetings.
The 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 CRS Project Manager and Vice President 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.
The Director of Biostatistics has a PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with five (5) years of relevant work experience OR a Master?s degree in Statistics or Biostatistics or a related health science field, and at least 8 years bio statistical experience in the clinical trials or health research environment. Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required. Ability to lead multi-functional teams across multiple locations.
Compensation & Benefits
Cytel offers a competitive salary-based package, bonus, comprehensive medical and dental benefits, plus a contributing 401K plan.
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