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Working under the direction of Biostatistics Management and / or Senior Biostatistician, the biostatistician performs the analysis of clinical trial data and provides statistical input into the reporting of clinical trial results. Responsibilities include :
As a Biostatistician 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. Validates 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.
Collaborates effectively with members of clinical trial implementation teams and with Biometrics colleagues.
Experience + Requirements
PhD degree in Statistics or Biostatistics, or a related field, with some applied statistics training relevant to the clinical trials or health research environment OR a Masters degree in Statistics or Biostatistics or a related field, and a preferred 1-5 years 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.
SAS proficiency including BASE and STAT; GRAPH preferred.