SCOPE

Exciting opportunity to join a growing biopharmaceutical company and lead a team of highly-qualified biostatisticians and programmers. Reporting to the VP of Biostatistics and Data Management, this position will support development activities for an exciting oncology clinical pipeline.

RESPONSIBILITIES

• Lead project team on quality control of integrated clinical reports
• Plan, monitor, organize and review activities of biostatisticians and programmers
• Contribute to feasibility assessments, clinical development plans, and regulatory submissions
• Protocol input, including study design, sample size calculations and patient randomization
• Review study database structures, edit checks and data management
• Prepare statistical analysis plans
• Interpret data and prepare reports on results
• Write statistical methods sections of integrated study reports

QUALIFICATIONS

• PhD in Statistics, Biostatistics, or Mathematics
• 5+ years statistics or biostatistics experience in the pharmaceutical industry
• Demonstrated knowledge of ICH guidelines, CDISC data structures, FDA guidelines and other industry standards
• Demonstrated knowledge of statistical and clinical trials methodology, including subgroup analysis, longitudinal data analysis, and predictive modeling,
• SAS programming knowledge

My team and I are working on a number of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or e.mato@hamlynwilliams.com.