Senior Biostatistician

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Job Title: Senior Biostatistician

Location: London Bridge, London (4 days on-site)

Term: Permanent, Full-time

Salary: Competitive + Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more)

Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies.

The Role:

We are now looking for a Senior Biostatistician to come on board to join the Statistics team, delivering analysis and insight into data gathered during phase I, phase II and phase III trials in healthy volunteers and in patient populations. This role will suit an experienced Biostatistician and previous experience of analysing clinical trials data is essential. Prior experience in a CRO is highly desirable and candidates who have worked in a client facing, role in the past will be given priority.

Main duties and responsibilities

• Input into study protocol to define the design, statistical methods and analysis to meet study objectives, including sample size calculations.
• Statistical Analysis Plana and tables, forges and listings shells
• Ability to identify outliers and data inconsistencies, Data review meeting listings preparation to define protocol deviations.
• Define methods to analyse unique datasets
• Experience in CDISC compliant datasets - SDTM and ADAM
• Prepare and analyse datasets according to study protocol and/or SAP
• Statistical programming (SAS), review and present results (TFLs) as per SAP
• Review and QC of statistical deliverables (tables, listings, figures, etc.)
• Assist in the analysis of the data for articles, posters and presentations
• Contribute into the update and development of company SOPs

Qualifications and Experience

• MSc, PhD or equivalent in Statistics or a Degree with strong statistical content
• Experience and 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 analyse, interpret, and draw conclusions from complex statistical information
• Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
• Good knowledge of CDISC standards (AdAM)
• Solid statistical programming skills in SAS and experience working with large datasets
• Good knowledge of MS office software
• Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Good time management and programme skills
• Strong written and verbal communication skills
• Interpersonal, teamwork and communication skills

Desirable

• Experience in early phases of clinical development (PK trials) and / or clinical data management.
• Participation in bid defence meetings and kick-off meetings
• Preparation and delivery of presentations at investigators' meetings
• Coaching and training of statisticians and SAS programmers
• Preparation for and attendance at internal and third-party study audits pertinent to Statistics
• Preparation of the answers to the internal/external audits findings/ recommendations, and follow-up on and resolution of audit findings.

Application:

If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.