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Principal Biostatistician, FSP
Clinical Outcomes Solutions. Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) independently from protocol design to reporting of results.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading statistical activities for clinical trials, utilizing SAS and R for data analysis and quality control, while providing oversight and mentorship to junior statisticians. Strong ability to collaborate with cross-functional teams and contribute to safety reporting and regulatory submissions.
Highest-signal resume keywords
SAS ProgrammingR ProgrammingClinical Trials SupportStatistical AnalysisLeadership in Statistics
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical MethodsMachine LearningDeep Learning AlgorithmsInferential Statistical AnalysesModelling/SimulationQC of DatasetsEfficacy/Safety TablesExploratory AnalysesIntegrated Analytical ApproachesSafety Reporting
Soft Skills
Effective CommunicationInterpersonal SkillsAttention to DetailInnovative LeadershipCollaboration
Tools & Technologies
SASRR ShinyPython
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryClinical TrialsHealth AuthoritiesCRO Contributions
Tech Stack
Tools & technologiesPython
About the role
Key responsibilities & impact- 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.
- Collaborate effectively with all cross-functional stakeholders.
- Oversee internal programming activities and/or CRO contributions on assigned clinical trials.
- Contribute to or lead Safety Reporting, ISS/ISE, responses to Health Authorities, and Publications.
- Use SAS and/or R for QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, and exploratory analyses.
- Contribute to initiatives at Cytel or sponsor side.
- Provide oversight of more junior Statisticians.
- Formulate integrated analytical approaches using statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate recurring processes.
Requirements
What you’ll need- 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
Comp & perks- Consistent training, development and support
- Significant professional growth
- Autonomy and ownership in work
- Support from Cytel while embedded with a pharmaceutical client