Principal Statistician

PSI CRO; Any-Martin-Rieux; À distance; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading CRO in Hauts-de-France is seeking an experienced Statistical Project Lead to contribute to global clinical trials. The ideal candidate will have expertise in biostatistics, SAS programming, and strong communication skills. Responsibilities include conducting statistical analyses, leading teams, and developing study protocols. A master's degree in Statistics is required, along with fluency in English. This full-time role offers a dynamic work environment and opportunities for professional growth.

Qualifications

• Expert knowledge of statistical principles and methods in clinical research.
• Strong proficiency in English.
• Ability to interpret complex statistical information.

Responsabilités

• Lead biostatistics projects and teams.
• Conduct and review statistical analysis for clinical trials.
• Develop study protocols and statistical analysis plans.

Connaissances

Statistical analysis

SAS programming

CDISC ADaM standard

Adaptive designs

Sample size calculation

Communication skills

Statistical software

Formation

MSc in Statistics or equivalent

Outils

SAS

SPSS

R

Stata

Description du poste

Overview

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.

Responsibilities

• 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

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 well be there with you every step of the way.

Remote Work: 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