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Senior Principal Statistician, Biostatistics
Jazz Pharmaceuticals. Lead statistics for individual studies, related studies, integrated summaries, and regulatory filings .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical analysis and clinical trial design, with proficiency in SAS and R programming. Capable of leading statistical strategies and collaborating across clinical development teams to ensure compliance with regulatory standards.
Highest-signal resume keywords
Statistical AnalysisClinical Trial DesignSAS ProgrammingR ProgrammingRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Statistical PrinciplesHypothesis TestingSample Size CalculationsBayesian DesignAdaptive DesignPhase I/II Clinical TrialsData AnalysisStatistical MethodologyCDISC StandardsStatistical Simulation
Soft Skills
Excellent Communication SkillsLeadership AbilitiesAttention to DetailTime ManagementInterpersonal Skills
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryICH GuidelinesDrug Development RegulationsOncologyHematologyClinical Pharmacology
About the role
Key responsibilities & impact- Lead statistics for individual studies, related studies, integrated summaries, and regulatory filings
- Design and report Phase I to IV clinical studies
- Provide statistical expertise to clinical development projects
- Develop and execute statistical strategy, study designs, and clinical-trial analyses
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations
- Manage work performed by external statistics and programming vendors
- Participate in department and cross-functional meetings to optimize study designs, endpoints, and analysis strategies
- Support development and implementation of study protocols
- Review and help validate data capture systems
- Develop statistical programs for clinical-trial simulations, analyses, data displays, and validation
- Write and review statistical analysis plans
- Perform and oversee data analysis and validation, and interpret analyses
- Prepare for and attend regulatory-agency meetings
- Develop, implement, and maintain department standards and practices
- Review CRO timelines and analysis plans for timeliness and quality
- Review and validate CRO deliverables
- Act as statistical subject matter expert for clinical reports, integrated summaries, and other documents
- Respond to statistical questions from regulatory agencies
Requirements
What you’ll need- MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry, OR PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry
- Knowledge of clinical trial design and analysis, including complex statistical methods and models
- Knowledge of statistical principles and methodology, statistical inference, hypothesis testing, estimates, parametric and non-parametric models and techniques, sample size calculations, design of experiments, and Phase II-IV clinical trial data analysis
- Experience using SAS and R
- Knowledge of applicable regulatory requirements and guidelines, including ICH Guidelines, drug development regulatory requirements, statistical contributions to marketing applications, and CDISC standards
- Knowledge of drug development regulations pertinent to statistical analysis
- Proficient SAS and R programming skills
- Solid understanding of CDISC models and standards
- Excellent writing and communication skills
- Demonstrated leadership abilities and excellent interpersonal skills
- Ability to work in a fast-paced, flexible, team-oriented environment
- Strong attention to detail
- Ability to work without close supervision
- Well-developed time management skills
- Knowledge of oncology or hematology therapeutic area is preferred
- Bayesian and adaptive design experience is preferred
- Experience in Phase I/II Oncology studies and Phase I healthy volunteer/clinical pharmacology studies for Neuroscience is preferred
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Retirement savings plan
- Flexible paid vacation