job title:exprienced biostatistician(medpace)
2/10/20251 min read
Responsibilities
Contribute to clinical development plan preparation;
Review of study protocol and preparation of statistical methodologies;
Development of detailed Medpace Data Analysis Plan for assigned projects;
Programming of study analysis, review of study results and preparation of statistical methods
section for clinical/statistical reports;Communicate project requirements for CRF design, database design and database cleanup
to ensure the key study variables are suitable for analysis; andCommunicate statistical results to medical writing personnel to ensure accurate
interpretation.
Qualifications
Ph.D. degree in Biostatistics/Statistics with pharmaceutical clinical trial experience;
Strong experience in SAS® programming or equivalent;
Knowledge of other statistical software; of advanced statistical methods and knowledge of the pharmaceutical industry;
Knowledge of regulatory requirements/guidelines for drug development;
Familiarity with complex statistical methods that apply to Phase I-IV clinical trials;
Experience in generation of analysis databases, and analyses for medium to high complexity clinical trial projects including ISS, ISE, and electronic submissions;
Excellent verbal and written communication skills
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