Principal Statistician (Pharmacokinetics)

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

Zusammenfassung

Psi CRO Ag is seeking a full-time Biostatistics Project Lead in Munich, Germany. In this role, you will contribute to statistical activities supporting global clinical trials, ensuring effective communication across teams and clients. Duties include conducting statistical analyses, developing protocols, and leading SAS programming teams. The ideal candidate will have a Master’s degree in Statistics, expert knowledge in SAS and CDISC ADaM standards, and strong analytical skills.

Qualifikationen

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

Aufgaben

• Act as a liaison for project teams on statistical questions.
• Conduct statistical analysis for clinical trials.
• Develop and review study protocols and statistical analysis plans.

Kenntnisse

Statistical analysis

SAS programming

Communication skills

Knowledge of CDISC ADaM standard

Pharmacokinetics principles

Advanced statistical techniques

Ausbildung

MSc in Statistics or equivalent

Tools

Phoenix WinNonlin

Jobbeschreibung

Full-time

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
• 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 pharmacokinetics principles, concepts, methods and standards used in clinical research, including the conduct NCL and population PK analysis
• Expert knowledge and understanding of Phoenix WinNonlin and NLME
• Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Ability to apply a range of 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

Please submit your CV in English.