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Principal Statistician (Pharmacokinetics)
PSI CRO —Oxford
- Full-time
- Remote
- English
- Master's degree
- Communication skills
Quick apply
Principal Statistician
PSI CRO —Oxford
- Full-time
- Remote
- Master's degree
- Communication skills
Quick apply

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Principal Statistician (Pharmacokinetics)

PSI CRO -
Oxford

Quick apply

Job details

Full-time

Qualifications

Clinical research
SAS
English
Master's degree
Statistical analysis
Communication skills

Full job description

Company Description

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 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

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.

Quick apply

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