Principal Statistician

PSI; Oxford; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading Clinical Research Organization is seeking a Biostatistics Project Lead to contribute to statistical activities related to global clinical trials. The ideal candidate will ensure proper statistical analysis, develop study protocols, and lead teams of statisticians and programmers. An MSc in Statistics or equivalent and expert knowledge of SAS programming and regulatory guidelines are required. This position offers an opportunity to work with international teams and make a significant impact in clinical research.

Qualifications

• MSc in Statistics or equivalent.
• Strong knowledge of statistical methods in clinical research.
• Proficient in SAS programming.

Responsibilities

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

Skills

Statistical principles

SAS programming

CDISC ADaM standard

Adaptive designs

Sample size calculation

Regulations and guidelines (FDA, EMA, ICH)

Communication skills

Statistical analysis techniques

Education

MSc in Statistics or equivalent

Job description

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
• 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

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.