Senior Biostatistician

October 31

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Logo of Clinical Outcomes Solutions

Clinical Outcomes Solutions

Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics

51 - 200

Description

• An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods. • Support or lead one or more Phase I-IV clinical studies. • Working fully embedded within one of our pharmaceutical clients, you’ll be at the heart of their innovation. • Perform ad-hoc or exploratory analyses to support submission or Health Authority Questions. • Support medium complexity clinical trials from Design to Archival experience.

Requirements

• Master’s degree in statistics or a related discipline. Ph.D. strongly desired. • 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 & implementation of CDISC requirements for regulatory submissions. • Adept in ADaM specifications generation and QC of datasets. • The ability to build strong external & internal relationships and motivate a regional or global team. • Effective communicator: able to explain methodology and consequences of decisions in lay terms.

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