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The Biostatistician II performs the analysis of clinical trial data and provides statistical input into the reporting of clinical trial results, working to the large extent independently with minimal oversight from the Director or Manager of Biostatistics or Senior Biostatistician.
As a Biostatistician II You Will...
Provide 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).
Communicate with clients regarding study protocol or statistical analysis issues.
Write detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.
Analyze clinical trial data producing accurate results representing the outcome of the trial. Validate statistical output.
Accurately interpret statistical results and concepts.
With the medical writer, 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.
Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.
g., statistical methodology standards, standard data presentations).
Participate in interactions with regulatory agencies, as required.
Collaborate effectively with members of clinical trial implementation teams and with Biometrics colleagues.
Experience + Requirements
Master’s degree in Statistics, Biostatistics, or a related field, plus 2-5 years of biostatistical experience in the clinical trials or health research environment required;
PhD in Statistics, Biostatistics, or related field with some applied statistics training relevant to the clinical trials or health research environment, plus at least 1 year of relevant work experience preferred.
Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials.
SAS proficiency including BASE and STAT; GRAPH preferred.