Senior Biostatistician at Cytel

The Senior Biostatistician 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 Biostatistician 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 Biostatistician also provides statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

The Senior Biostatistician 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 Biostatistician collaborates 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.

Qualifications and Experience:

• Master's degree in Statistics or Biostatistics
• 5-8 years statistical analysis related to clinical trials or health research environment
• 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
• SAS and R proficiency