Clinical Outcomes Solutions

Principal Biostatistician, FSP

Clinical Outcomes Solutions

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Lead

Tech Stack

Python

About the role

  • Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) independently from protocol design to reporting of results.
  • Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
  • Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
  • Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
  • Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
  • Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
  • Oversight of more junior Statisticians as required.

Requirements

  • Minimum of Bachelor's degree in statistics or a related discipline.
  • 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  • Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
  • Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours.
  • SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
  • Knowledge of R programming (R Shiny/Python)
Benefits
  • Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
  • We work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful.
  • Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
statistical analysisSAS programmingR programmingQC of datasetsinferential statistical analysesmodellingsimulationexploratory analysesEfficacy tablesSafety tables
Soft Skills
leadershipinitiativeflexibilityattention to detailquality focusedinterpersonal skillscommunication skillsinnovativecollaborative
Certifications
Bachelor's degree in statistics