The Principal Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:Serves as the responsible biostatistician on Phase I to III clinical trials, ranging from relatively simple or complex. Contributes to clinical study synopses and protocols. Develops statistical analysis plans and/or performs senior review of statistical analysis plans. Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies. Provides relevant input in the development and review of CRFs. Performs lead review and sets up internal QC of TFLs. Performs critical review of derived datasets specifications and derived datasets (ADaM). Contributes to clinical study reports. Reviews simple to complex randomization specifications and dummy randomization schemes. Participates in bid defense meetings. Oversight of project financials. Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI). Contributes to press releases and scientific papers.
Skills and Experience:Masterâs degree in statistics or biostatistics required. Minimum of 6-8 years of biostatistical experience, plus lead statistician experience. Experience in handling CROs and vendors. Experience with Data Monitoring Committees (DMC's) Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices. Proficient with other statistical software such as R, EAST, Winbugs is a plus. Detailed knowledge of and experience with CDISC standards is desired. Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials. Displays excellent communication skills with proven leadership ability. Knowledge of ICH-GCP and other applicable legislation to successfully implement the clinical study.
Physical Requirements / Work Environment
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