Senior Statistician

PSI CRO AG

Senior Statistician contributing to statistical activities related to global clinical trials. Collaborating with international teams on various analysis and protocols while ensuring compliance with standards.

Posted 7/30/2026full-timeRemote • North Carolina • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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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. Capable of leading teams and providing training while ensuring compliance with relevant regulations and guidelines.

Highest-signal resume keywords

MSc In StatisticsExpert Knowledge Of SAS ProgrammingExpert Knowledge Of CDISC ADaM StandardExpert Knowledge Of Statistical PrinciplesExpert Knowledge Of Relevant Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisAdaptive DesignsSample Size CalculationStatistical Analysis PlansAnalysis Dataset Specifications

Soft Skills

Strong Presentation SkillsCommunication Skills

Industry Keywords

Clinical TrialsFDAEMAICHQuality Systems Documents

About the role

Key responsibilities & impact

Act as a communication line for project teams, clients, vendors and internal team on statistical questions
Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis
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 (QSDs) 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