Principal Statistician

Psi CRO Ag; München; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Psi CRO Ag is looking for a Biostatistics Project Lead in Munich to contribute to statistical activities related to global clinical trials. The role involves leading statistical analysis, developing and reviewing study protocols, and ensuring quality deliverables. Ideal candidates will have an MSc in Statistics, full proficiency in English, and expert knowledge in statistical methods, SAS programming, and CDISC standards. Join an international team dedicated to clinical research excellence.

Qualifikationen

• Full working proficiency in English.
• Expert knowledge and understanding of statistical principles and methods used in clinical research.
• Ability to analyze and interpret complex statistical information.

Aufgaben

• Act as communication line for project teams on statistical questions.
• Conduct statistical analysis for clinical trials including interim and final analysis.
• Develop and review study protocols and statistical analysis plans.
• Review statistical deliverables such as tables and figures.
• Conduct departmental induction course for statisticians and SAS programmers.

Kenntnisse

Statistical principles

SAS programming

CDISC ADaM standard

Adaptive designs

Sample size calculation

Regulations and guidelines (e.g. FDA, EMA, ICH)

Advanced statistical techniques

Presentation and communication skills

Ausbildung

MSc in Statistics or equivalent

Jobbeschreibung

Job Description

You will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers, including the role of biostatistics project lead.

In this role, you will:

• 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

Qualifications

• MSc in Statistics or equivalent
• Full working proficiency in English
• 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