Sr Manager, Biostatistics
Foster City, CA, USA | Leading Pharmaceutical / Biotech Company
Industry:Pharmaceutical / Biotech
Consulting - IT
Job Description:1 people have viewed this job
Lead multiple studies’ safety analyses for investigator brochure (IB), Drug Safety Update Reports (DSUR), periodic safety update and integrated safety analyses.
Work collaboratively with Statistical Programmers, Drug Safety, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
Provide input into IB, DSUR, protocols, clinical study reports and integrated safety summaries for regulatory submissions; author or review program safety statistical analysis plans; coordinate with other study biostatisticians and statistical programmers to prepare the statistical analyses for IB, DSUR update, integrated safety outputs, periodic safety update and other ad hoc safety analyses; participate in cross-functional study-related activities, attend team meetings; provide statistical support to publications and presentations. Leads initiatives to gather, organize, and analyze safety related data for Case Report Forms, analysis plan, and data specification.
Working knowledge of advanced statistical methodologies, SAS programming skills and familiarity with industry standards are necessary for this role.
Excellent verbal and written communication skills and interpersonal skills are required.
Prior experience of integrated safety analyses and/or statistical analysis in oncology therapeutic area are highly preferred.
KNOWLEDGE, EXPERIENCE & SKILLS:
8+ years of pharmaceutical or biotechnology industry experience as a statistician and an MS degree in Biostatistics or equivalent 4 years of pharmaceutical or biotechnology industry experience as a statistician with a PhD degree in Biostatistics or equivalent