Senior Biostatistician

4 weeks ago


London, Greater London, United Kingdom Richmond Pharmacology Full time

Job Title: Senior Biostatistician

Location: Remote

Term: Permanent, Full-time

Salary: Competitive + Benefits

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 seeking a highly experienced Senior Biostatistician to join our 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 with a strong background in clinical trials data analysis.

Main duties and responsibilities:

  • Develop and implement statistical analysis plans to meet study objectives, including sample size calculations.
  • Design and implement statistical methods and analysis to meet study objectives.
  • Identify and resolve data inconsistencies and outliers.
  • Develop and implement 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 to 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.



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