Senior Statistician

PSI CRO; Oxford; On-site; GBP 70,000 - 100,000; Full time

Job summary

PSI CRO in the United Kingdom seeks an experienced statistician to lead all biostatistics activities for clinical trials. You will collaborate with project teams, clients and vendors to address statistical questions and ensure robust designs.

The role covers developing and reviewing protocols, SAPs, data structures, SAS programs, and reports, while training junior statisticians and presenting at investigators' meetings.

Qualifications

• MSc in Statistics or equivalent.
• Expert knowledge of statistical principles used in clinical research.
• Ability to apply advanced statistical techniques in clinical studies and to interpret results.
• Ability to consult with clinical investigators and determine analysis strategies.
• Expert knowledge of SAS programming.
• Expert knowledge of CDISC ADaM standards.
• Knowledge of FDA, EMA, ICH guidelines.
• Ability to work in English.

Responsibilities

• Lead all biostatistics activities related to clinical trials as responsible project statistician.
• Communicate with project teams, clients and vendors on statistical questions.
• Develop and review statistical sections of protocols, including sample size calculations.
• Develop statistical analysis plans.
• Develop and document analysis database structures (e.g. SAS analysis data set structures).
• Develop SAS program requirements and specifications.
• SAS programming and program validation.
• Review and QC of statistical deliverables (tables, listings, figures, etc.).
• Perform statistical analysis and report results.
• Consult on experimental design and statistical methods for assessing safety and efficacy of drug products.
• Liaise with DM on statistical questions related to data issues, including data transfers.
• Participate in bid defense meetings and kick-off meetings.
• Train statisticians and SAS programmers.
• Prepare and deliver presentations at investigators' meetings.
• Address audits findings and follow-up on audit recommendations.

Skills

Biostatistics

Statistical analysis

Clinical trial design

Communication with stakeholders

Regulatory knowledge

Education

MSc in Statistics or equivalent

Tools

SAS

CDISC ADaM

Job 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

In this role, you will:

• Lead all biostatistics activities related to clinical trials as responsible project statistician
• Communicate with project teams, clients and vendors on statistical questions
• Develop and review statistical sections of protocols, including sample size calculations
• Develop statistical analysis plans
• Develop and document analysis database structures (i.e. SAS analysis data set structures)
• Develop SAS program requirements and specifications
• SAS programming and program validation
• Review and QC of statistical deliverables (tables, listings, figures, etc.)
• Perform statistical analysis and report results
• Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
• Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
• Participate in bid defense meetings and kick-off meetings
• Train statisticians and SAS programmers
• Prepare and deliver presentations at investigators' meetings
• Address audits findings/recommendations, and follow-up on and resolution of audit findings

Qualifications

• MSc in Statistics or equivalent
• Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
• 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
• Expert knowledge and understanding of the SAS programming
• Expert knowledge and understanding of CDISC ADaM standard
• Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Ability to work 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.