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Principal Statistician, Biostatistics
Jazz Pharmaceuticals. Support the design and reporting of Phase I to IV clinical studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial design and statistical analysis, with proficiency in SAS and R programming. Capable of developing statistical strategies and collaborating across multidisciplinary teams to ensure compliance with regulatory standards.
Highest-signal resume keywords
Clinical Trial DesignStatistical AnalysisSAS ProgrammingR ProgrammingRegulatory Requirements
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Statistical MethodsStatistical InferenceHypothesis TestingSample Size CalculationsExperimental DesignPhase II-IV Clinical Trial Data AnalysisCDISC ModelsStatistical Program DevelopmentData ValidationStatistical Analysis Plans
Soft Skills
Excellent WritingCommunication SkillsInterpersonal SkillsLeadership SkillsAttention to Detail
Industry Keywords
ICH GuidelinesPharmaceutical IndustryBiotechnology IndustryDrug Development RegulationsClinical DevelopmentPharmacovigilanceClinical Data ManagementRegulatory FilingsCRO GuidelinesStatistical Programming
About the role
Key responsibilities & impact- Support the design and reporting of Phase I to IV clinical studies
- Support regulatory filings under the supervision of a more senior statistician
- Lead statistical aspects of study design, analysis, validation, and documentation
- Provide statistical expertise for clinical trials, including early-stage trials
- Develop and execute statistical strategy, design, and analyses
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations
- Oversee statistics and programming work performed by external vendors
- Participate in data science and cross-functional meetings to optimize study designs, endpoints, and analysis strategies
- Support study protocols and review and validate study-specific data capture systems
- Develop statistical programs for clinical trial simulations, analyses, data displays, and validation
- Write statistical analysis plans, perform data analysis and validation, and interpret analyses
- Support the project lead statistician
- Prepare for and attend regulatory agency meetings and respond to statistical questions
- Work closely with statistical programming colleagues
- Monitor CRO guidelines and standards and review and validate CRO deliverables
- Collaborate with medical writers on clinical reports, integrated summaries, and other documents
- Learn and apply drug development regulatory requirements, including CDISC SDTM and ADaM standards
- Stay current with developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional development
Requirements
What you’ll need- Knowledge of clinical trial design and analysis, including complex statistical methods and models
- Knowledge of statistical principles and methodology, including statistical inference, hypothesis testing, estimates, parametric and non-parametric models, sample size calculations, experimental design, and Phase II-IV clinical trial data analysis
- Experience using SAS and R; knowledge of other statistical applications and programming languages is a plus
- Knowledge of applicable regulatory requirements and guidelines, including ICH Guidelines
- MSc in statistics, mathematics, or a related discipline with a statistical focus and more than 2 years of pharmaceutical or biotechnology industry experience, or PhD in statistics, mathematics, or a related discipline with a statistical focus and less than 2 years of pharmaceutical or biotechnology industry experience
- Knowledge of drug development regulations pertinent to statistical analysis
- Proficient SAS and R programming skills
- Understanding of CDISC models and standards
- Excellent writing, communication, interpersonal, and leadership skills
- Ability to work in a fast-paced, flexible, team-oriented environment
- Strong attention to detail
- Ability to work without close supervision with effective time management
Benefits
Comp & perks- Medical, dental and vision insurance
- Retirement savings plan
- Flexible paid vacation