Principal Statistician

PSI CRO; Italia; Remoto; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

A leading contract research organization is looking for a Biostatistics Project Lead to contribute to statistical activities for global clinical trials. You will work closely with international teams and lead statistical analyses, ensuring adherence to statistical standards and methodologies. Ideal candidates should possess an MSc in Statistics and expert knowledge of SAS programming. This role offers full-time employment and flexible remote work options.

Competenze

• MSc in Statistics or equivalent required.
• Full working proficiency in English is essential.
• Expert knowledge of statistical methodologies used in clinical research.

Mansioni

• Act as a 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.

Conoscenze

SAS programming

Statistical principles

CDISC ADaM standard

Adaptive designs

Sample size calculation

Clinical research

Data Analysis Skills

Statistics

Communication skills

Formazione

MSc in Statistics or equivalent

Strumenti

SPSS

R

Stata

Descrizione del lavoro

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 and follow up
• Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department
• Liaise with Data Management 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 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 we'll 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