Clinical Vacancies

Biostatistician/SAS Programmer

Salary: depending on experience plus full benefits

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
  • 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.

No contact from agencies please

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