Senior Manager – Biostatistics

Role Overview

• Provide statistical expertise and input to clinical development programs
• Author detailed statistical analysis plans including the evaluation of study objectives/endpoints, the structure and content of analysis datasets, derivation of variables and sample size/power calculation
• Plan the contents and format of tables, listings and figures (TLFs) to be programmed for the clinical study report (CSR)
• Review CDISC datasets and associated documentation/metadata
• Review Data Management associated documentation and setup of databases
• Support the generation of posters and publications
• Develop statistical programs for data review including detailed listings to identify data issues and vendor reconciliation
• Conduct statistical programming as needed to support quality control of analyses and the success of clinical development programs
• Review and provide input on project related clinical documents from a statistical perspective including protocols, development safety update reports, investigator brochures, and CSRs
• Assist with development of SOPs and quality procedures for biostatistics

Requirements

• Master’s Degree in Biostatistics required
• PhD Degree preferred
• Minimum 4-6 years of biostatistics experience working in the pharmaceutical industry required
• Must be proficient in SAS with an understanding of CDISC datasets standards
• Familiarity with Phoenix WinNonlin for non-compartmental analyses preferred
• Advanced and broad knowledge of statistical methods and an understanding of pharmaceutical industry practices
• Must be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skills
• Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
• Ability to establish and maintain collaborative working relationships with internal and external stakeholders.