Principal Statistician (Pharmacokinetics)

PSI CRO; France; À distance; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading CRO is looking for a Biostatistics Project Lead to contribute to global clinical trials. The role requires an MSc in Statistics and expertise in SAS programming, statistical analysis, and CDISC standards. Responsibilities include leading teams, conducting analyses, and reviewing deliverables. Remote work is available for this full-time position.

Qualifications

• Full working proficiency in English.
• Expert knowledge of statistical principles in clinical research.
• Ability to interpret research requirements and determine analysis strategies.

Responsabilités

• Lead teams of SAS programmers and/or statisticians on projects.
• Conduct statistical analysis for clinical trials.
• Review statistical deliverables such as tables and listings.

Connaissances

SAS programming

Statistical analysis

Expert knowledge of CDISC ADaM standard

Pharmacokinetics principles

Strong presentation skills

Regression Analysis

Clinical Trials

Statistical Software

Data Analysis Skills

Formation

MSc in Statistics or equivalent

Outils

Phoenix WinNonlin

SPSS

R

Stata

Description du poste

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, final 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 of 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.

Additional Information :

Our mission is to be the best CRO in the world as measured by our employees, clients, sites and vendors. Our recruitment process is easy and straightforward and we will be there with you every step of the way.

Remote Work : Yes

Employment Type : Full‑time

Key Skills

Spss, R, Regression Analysis, Stata, Survival Analysis, Clinical Trials, Statistical Software, Data Mining, SAS, Statistics, Data Analysis Skills, Statistical Analysis

Experience : years

Vacancy : 1