Statistician Biostatistician - Expert In Recruitment Solutions
San Mateo, CA 94402
About the Job
| 100% remote Statistician Biostatistician Job Description: This role involves supporting study teams for Analysis & Reporting of Clinical trial data by taking end to end independent responsibility of assigned projects for all Biostatistics and Analysis & reporting tasks. Senior Statistician ensures the use of appropriate and efficient statistical analysis methods during development, submission and/or life-cycle management products according to applicable global and regional standards, procedures and regulatory guidelines. Technical Skills: • Provides statistical and methodological consultation and contributes to multi-disciplinary and multi-company teams. • Provide statistical support for case report form design, database development, data validation plan and blinded data review as and when required. • Support and lead DMC/IA activities as blinded or unblinded Statistician and lead programming team as per requirement • Development of Statistical Analysis Plan (or equivalent) including table shells design. • Perform statistical programming to generate tables, listings, figures, and statistical analysis. • Conduct literature searches to support statistical analysis. • Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health authorities. • Responds to inquiries from health authorities and other internal or external partners and participate in client or regulatory audits. • Contribute to clinical trial result interpretation and facilitate discussions on the same. • Guide cross functional teams – Data management and medical writers for all trial related activities Qualifications and/or Experience: • PhD or MS in Biostatistics, Statistics or Mathematics • At least 6+ years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector • Thorough knowledge of the pharmaceutical or Medical devices industry including understanding of clinical drug development process and associated documents and regulations. • Experience in leading teams • Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively as required • Good knowledge of statistical programming languages (including SAS) |
Source : Expert In Recruitment Solutions
