Your responsibilities will 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.
Additionally, you will analyze clinical trial data producing accurate results representing the outcome of the trial, validate statistical output, accurately interpret and clearly communicate statistical results and concepts to non-statisticians. With the medical writer, you will co-author final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report. You also will provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
In this role you will provide input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participate in interactions with regulatory agencies, as required. You will be expected to collaborate effectively with members (internal and external) of clinical trial implementation teams and with Biometrics colleagues, and keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
Qualifications and Experience
You will have a PhD degree in Statistics or Biostatistics or related field with some applied statistics training relevant to the clinical trials or health research environment, and one (1) year of relevant work experience or a Master’s degree in Statistics or Biostatistics or a related health science field and at least 5 years of statistical experience in the clinical trials or health research environment.
Additionally, we require 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.