Principal Statistician (Pharmacokinetics)

PSI CRO; Oxford; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global clinical research organization is seeking a Biostatistics Project Lead in Oxford to oversee statistical activities in clinical trials. The ideal candidate will possess an MSc in Statistics and extensive expertise in statistical analysis and SAS programming. Key responsibilities include conducting analyses, developing statistical plans, and liaising with project teams and clients. Strong communication skills are essential. This role offers a chance to work at the cutting edge of medical science.

Qualifications

• Full working proficiency in English is required.
• Expert knowledge in statistical principles and clinical research methods.
• Ability to apply advanced statistical techniques.

Responsibilities

• Act as a communication line for statistical queries.
• Conduct statistical analyses for clinical trials.
• Develop and review statistical analysis plans.

Skills

Statistical analysis

SAS programming

Research consultation

Communication skills

Education

MSc in Statistics or equivalent

Tools

Phoenix WinNonlin

CDISC ADaM standard

Job description

Overview

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

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 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 WinNonlea 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

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.