Senior Biostatistician

• Support or lead one or more Phase I-IV clinical studies
• Perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions
• Provide statistical support to clinical studies
• Participate in study protocol development, study design discussions, and sample size calculations
• Review CRFs and data review guidelines
• Develop statistical analysis plans, including analysis dataset and TLG specifications
• Perform statistical analyses and interpret statistical results
• Prepare clinical study reports, including integrated summaries for submissions
• Present and explain methodology and consequences of decisions
• Understand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelines
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in development of CRFs, edit check specifications, and data validation plans
• Review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions to meet project timelines and goals
• Review and/or author SOPs and work instructions related to statistical programming practices

• Master’s degree in statistics or a related discipline
• 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry
• Experience working for a CRO is strongly desired
• Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers
• Knowledge of R programming is a plus
• Solid understanding and implementation of CDISC requirements for regulatory submissions
• Adept in ADaM specifications generation and QC of datasets
• Ability to build strong external and internal relationships and motivate a regional or global team
• Effective communication skills, including explaining methodology and consequences of decisions in lay terms

• Consistent training, development and support
• Significant professional growth opportunities