Principal Statistician

Psi CRO Ag; France; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Psi CRO Ag in France is seeking a Biostatistics Project Lead to contribute to statistical activities for global clinical trials. Responsibilities include conducting statistical analyses, leading teams, and preparing study protocols. The ideal candidate will have an MSc in Statistics, expertise in SAS programming and CDISC standards, along with strong communication skills. This role is an excellent opportunity to work with international teams and support the success of clinical research initiatives.

Qualifications

• Full working proficiency in English is required.
• Expert knowledge of statistical principles used in clinical research.
• Ability to apply advanced statistical techniques.

Responsabilités

• Act as the communication line for project teams and clients.
• Conduct statistical analysis for clinical trials.
• Review statistical deliverables and protocols.
• Prepare for and attend study audits.
• Lead teams of SAS programmers and statisticians.

Connaissances

Statistical principles and concepts

SAS programming

CDISC ADaM standard

Adaptive designs

Sample size calculation

Communication skills

Analysis of statistical data

Formation

MSc in Statistics or equivalent

Description du poste

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