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Principal Statistician
PSI CRO AGPrincipal Statistician contributing to global clinical trials for a dynamic healthcare company. Leading statistical activities and collaborating with international teams on project deliverables.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expert knowledge in statistical principles and SAS programming, with a strong ability to conduct statistical analysis for clinical trials and develop study protocols according to CDISC ADaM standards. Proven skills in leading teams and communicating effectively with diverse stakeholders in clinical research.
Highest-signal resume keywords
MSc In StatisticsExpert Knowledge Of SAS ProgrammingExpert Knowledge Of CDISC ADaM StandardExpert Knowledge Of Statistical PrinciplesStrong Presentation And Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Statistical AnalysisSample Size CalculationAdaptive DesignsStatistical Analysis PlansAnalysis Dataset SpecificationsStatistical Deliverables ReviewQuality Systems DocumentsStatistical Techniques ApplicationClinical Research AnalysisStudy Protocol Development
Soft Skills
Communication SkillsTeam LeadershipConsultation SkillsPresentation Skills
Industry Keywords
Clinical TrialsFDA RegulationsEMA GuidelinesICH GuidelinesBiostatisticsData ManagementStatistical QuestionsInternal/External AuditsBid DefenseKick-Off Meetings
About the role
Key responsibilities & impact- Contribute to statistical activities related to global clinical trials
- Work closely with international teams of statisticians, programmers and data managers
- Act as a communication line for project teams, clients, vendors and internal team on statistical questions
- Conduct statistical analysis for clinical trials
- Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents
- Review statistical deliverables such as tables, figures, listings and analysis datasets
- Conduct departmental induction course and project-specific training for statisticians and SAS programmers
- Prepare for and attend internal and external study audits pertinent to Statistics
- Participate in preparation of internal/external audits follow up
- Provide input to standard operating procedures and other Quality Systems Documents pertinent to activities of Biostatistics department
- Liaise with DM on statistical questions related to data issues
- Participate in bid defense and in kick-off meetings
- Lead teams of SAS programmers and/or statisticians on the project level
Requirements
What you’ll need- MSc in Statistics or equivalent
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
- Expert knowledge and understanding of the SAS programming
- Expert knowledge and understanding of CDISC ADaM standard
- Expert knowledge and understanding of adaptive designs
- Expert knowledge and understanding of sample size calculation
- Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
- Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
- Strong presentation and communication skills
Benefits
Comp & perks- Employees can work remotely