Senior Biostatistician - Publications

3 days ago

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Clinical Outcomes Solutions

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

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Experienced Biostatistician supporting Phase I-IV clinical studies • Dedicated role within a global pharmaceutical client • Perform ad-hoc analyses to support submissions or health authority questions • Exposure to regulatory work is a bonus

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.

Benefits

• Comprehensive and competitive total reward package • World-class employee benefits • Supportive policies and wellbeing initiatives