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.

We are experiencing exponential growth on a global scale and hiring an Associate Director to join our PBSdivision. You will exercise your strong communication and leadership skills to support or lead one or more clinical trials, across various therapeutic areas. You will report to the Director, Biostatistics.

The Associate Directorprovides 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 Associate Directoranalyzes 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 Associate Directoralso provides statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

The Associate Directorprovides 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 Associate Directorcollaborates effectively with members 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 Associate 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.

Skills:

• Excellent written and oral communication skills, including grammatical/technical writing skills
• Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
• SAS proficiency including BASE and STAT

Qualifications and Experience:

• Minimum Education and Work Requirements: PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment and with eight (8) years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field and at least 10 years statistical experience in the clinical trials or health research environment

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Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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