•Assist clinical team in designing clinical trials and prepare all statistical sections of clinical protocols using appropriate statistical methodology for the specific trial, including selection of study design, sample size, and analyses.
•Work with the clinical data management and SAS programming team members to develop all statistical tables and listings for interim analyses and final study reports.
•Review database design, CRFs/eCRFs, and edit checks.
•Prepare statistical analysis plans.
•Review and validate all tables and statistical output for preparation of study reports.
•Prepare statistical sections for relevant background documents for EU, Africa, and U.S. regulatory agencies.
•Work with the Immunology department to develop guidelines for human assay qualification and validation protocols, and prepare study reports for assay validation.
•Assist the Animal Studies and Pre-Clinical Departments to design and analyze animal challenge studies.
•Master’s Degree in Statistics, Biostatistics, or related discipline; Ph.D. preferred.
•7+ years experience with drug development statistical analysis with a biotechnology or pharmaceutical company.
•Proficiency in SAS programming.
•Knowledge of experimental design, power calculations, survival analysis, and linear models.
•Familiarity with current ICH guidances pertinent to clinical development.
•Previous experience in EU regulatory submissions a plus.
•Designs of experiments (DOE) and/or media development a plus.
•Excellent oral and written communication skills.
•Proven ability to coordinate multi-disciplinary project teams.
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