Syneos Health

Principal Biostatistician, Medical Affairs

Syneos Health

full-time

Posted on:

Origin:  • 🇨🇦 Canada

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Job Level

Lead

About the role

  • Provide support to clinical study and/or project teams on all relevant statistical matters
  • Provide input into study design, protocol development, setup and conduct to ensure data capture supports objectives and planned analyses
  • Accountable for statistical deliverables: protocol sections, sample size calculation, randomization specifications, statistical methodology, SAP, data surveillance, statistical analysis results for CSR and appendices (TLGs and tables)
  • Utilize external groups (e.g., CROs, DMCs) effectively
  • Work with programming team on definitions, documentation, derived variables, and QC plans
  • Perform or coordinate production of statistical analyses and review data distributions/properties
  • Oversee execution of analyses per SAP, prepare statistical methods, and provide statistical insight for CSR and publications ensuring integrity and regulatory compliance
  • Propose and perform exploratory and ad-hoc analyses relevant to study objectives
  • Contribute to transparency and disclosure deliverables
  • Plan and track study/project activities and timelines
  • Ensure productive collaboration with other functions, promoting teamwork, quality, operational efficiency, and innovation

Requirements

  • Previous experience leading medical affairs clinical studies is required
  • PhD/MS in statistics or related discipline
  • At least 5 years of pharmaceutical experience
  • Good knowledge of pharmaceutical clinical development, including late phase and/or post-marketing activities
  • Broad knowledge and good understanding of advanced statistical concepts and techniques
  • Able to work in departmental computing environment and perform advanced statistical analyses using SAS and possibly other languages (e.g., R)
  • Demonstrated strong interpersonal, communication, and writing skills
  • Working experience in clinical development including interaction with external stakeholders