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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. The Senior Biostatistician can work independently and function as a lead statistician on clinical trials. 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.
Primary Duties + Responsibility:
- 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.
- Provides statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications.
- 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.
- 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.
Experience & Minimum Requirements:
- PhD degree in Statistics, Biostatistics, or related field, and 3 years of biostatistical experience in the clinical trials or health research environment OR a Master’s degree in Statistics or Biostatistics or a related field, and 5 years of biostatistical 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.
- Familiarity with SAS, SPSS or other statistical software package.
- Proficiency in Microsoft Word and Excel.
- Strong level of detail orientation.
- Ability to work on multiple tasks under tight timelines.