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Senior Biostatistician

7 months ago

London, United Kingdom Richmond Pharmacology Full time

Richmond Pharmacology's continued growth and increasing involvement in patient studies has led to a huge drive in recruitment across all departments.

**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.

**Requirements**:

- 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
- 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.

If you believe you have the skills and the experience to succeed in a role of this nature, please register your interest via our Bamboo HR system. You will be asked to supply a CV and contact details as a minimum.