Principal Statistician (Pharmacokinetics)

PSI CRO; Madrid; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

A global clinical research organization is seeking a Biostatistics Project Lead to contribute to statistical activities in clinical trials. You will manage communication across teams and conduct various statistical analyses. The ideal candidate must have an MSc in Statistics and expert knowledge of SAS programming and statistical principles. This role demands strong communication skills and the ability to handle complex statistical data. Applicants should submit their CVs in English.

Formación

• Expert knowledge of statistical principles, concepts, methods in clinical research.
• Full working proficiency in English.
• Ability to apply advanced statistical techniques.

Responsabilidades

• Act as a communication line for project teams and clients.
• Conduct statistical analysis for clinical trials.
• Develop and review study protocols and analysis plans.

Conocimientos

Statistical analysis

SAS programming

Communication skills

Statistical principles

Pharmacokinetics principles

Educación

MSc in Statistics or equivalent

Herramientas

Phoenix WinNonlin

CDISC ADaM standard

Descripción del empleo

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
• 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.

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.