Senior Statistician

Highly Competitive
  1. Permanent
  2. Statistics
  3. Spain
Madrid, Spain
Posting date: 17 May 2021

A leading and global Clinical Research Organisation is currently recruiting for a Senior Statistician to join their team based in Spain and Poland. They cover extensive clinical trials, which you are expected to lead. If you're a professional looking to further develop your statistical career, then this might be the role for you.

Job Responsibilities

  • Is responsible for all statistical activities regarding the assigned clinical studies, e.g. study design, sample size estimation, analysis plan, statistical analyses and reporting
  • Work independently with minimal support from the Head of Biostatistics Unit
  • Contribute to the design of clinical studies providing appropriate statistical methodology
  • Review the study objectives and endpoints with the study team and or the Sponsor and write detailed statistical analysis plan (SAP)
  • Generate randomisation lists or random selection procedures and collaborate with the Data Manager to produce the related documentation
  • Collaborate with the Data Management team to design review the study CRF, to define protocol deviations, edit checks and other data quality controls
  • Develop SAS programs and or collaborate with the SAS programmer to generate analysis, datasets, mock shells, TFLs for reporting and publications
  • Perform the quality control of deliverables generated by other statisticians or SAS programmers
  • Write the Statistical Report and/or the statistical sections of the Clinical Study Report
  • Track activities and milestones to ensure timely project deliverables
  • Liaise with Sponsor and external stakeholders regarding statistical activities and results of statistical analyses
  • Collaborate in establishing and maintaining SOPs related to Biostatistics
  • Organise trainings for project team and acts as a mentor for junior staff.

Skills and Requirements

  • Degree in Statistics (or equivalent degree) with a specialisation in medical or epidemiological statistics
  • At least 3 year of experience in CRO, biotech, pharma, research institutes or similar
  • Proven knowledge and expertise in statistics and its applications to clinical research
  • Solid knowledge and experience in drug development process and GCP guidelines
  • Solid knowledge of SAS and other statistical software packages
  • Experience in developing CDISC standard specifications and datasets (SDTM, ADaM)
  • Knowledge of computer systems related to clinical trials (EDC, IVRS, IWRDS, EPRO, CTMS, etc.)
  • Excellent communication and team-working skills

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.