Principal Biostatistician

3 days ago

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pfm medical, inc.

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Medical Device Manufacturing

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Description

• Provides statistical support for all phases of clinical development • Writing and reviewing statistical sections of protocols • Writing and reviewing statistical analysis plans including complex study designs • Conducting statistical analyses and presenting results to project teams and sponsors • Developing SAS programs for tables, listings, figures and analysis datasets • Generate and/or verify randomization schedules • Develop and review statistical methods of the clinical study protocol • Provide and/or verify sample size calculations • Author statistical analysis plans • Review statistical analysis plans written by other biostatisticians • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS • Perform quality control for statistical based SAS programs and other study documents • Provide or supervise programming and statistical support to supplemental or exploratory analyses • Provide statistical analysis and reports to Data Monitoring Committees

Requirements

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience or PhD degree with 7+ years experience • Experience with SAS • Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Broad knowledge and superior understanding of advanced statistical concepts and techniques • Preferred: Experience with Oncology and rare diseases • Preferred: Broad experience with late phase and/or submissions • Preferred: Experience in consulting with clients on study design • Preferred: Superior understanding of a specific therapeutic area and/or statistical methodology

Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation