Statistical Programmer – Home based (Senior to Principal Levels Available)

Job Summary

ICON/DOCS has entered into a large-scale Stats Programming FSP partnership with Novartis and is looking for experienced Statistical Programmers with at least 5 years SAS programming experience in clinical trials to create a team of >200 Programmers in EMEA and India.
As a member of this team you will be working closely with teams of Clinicians, Statisticians and Programmers at one of the top 5 pharma companies in the world which is recognized globally for its innovative therapeutic product pipeline and clinical development excellence which has produced game-changing medicines and transformed the lives of millions of patients around the world.

Roles & Responsibilities of the position

As a Statistical Programmer in this new team you will be involved in one or more clinical development programs spanning all phases of Clinical Research and your assignments would involve:

  • Supporting Global Submissions to FDA, EMA and PMDA (and other regulatory authorities)
  • Supporting key pivotal trials in late development compounds
  • Creating integrated efficacy/safety summaries and other submission related documents
  • Perform programming validation to ensure quality of analysis data sets and programming outputs
  • Provide comments to the design and checking of clinical trial database for proper data capture and data quality
  • Preparing analyses to support preparations for Advisory committees (ODAC and AdCom)
  • supporting HAQs as and when needed

All new trials are following CDISC standards and utilize cutting edge statistical reporting systems.
For candidates with the appropriate credentials and experience, there are opportunities to take on programming leadership roles at the Program and Trial-level,
coordinating teams of programmers to deliver high-quality analyses to support product development and commercial objectives. This is an exciting opportunity for motivated,
experienced Statistical Programmers to join one of the world’s largest providers of functional service solutions to the pharmaceutical industry and make a significant contribution
to the development of new medicines that will have a real benefit for patients around the world.

Job Requirements

  • At least 6-10 years previous clinical programming experience
  • Working knowledge of database design/structures and basic statistics
  • Good understanding of global clinical trial project practices, procedures, methodologies
  • Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
  • Strong knowledge of / experience with SAS and other relevant programming software.
  • Working knowledge of CDISC data standards including ADaM and SDTM

Remuneration & other details

As for DOCS, we are the Functional Resourcing Division (FSP) division of ICON Plc. This means that when you join the DOCS Team you will work exclusively with, and be fully dedicated to one of our many pharmaceutical / medical device partners working on their SOPs, IT Systems, Projects and sometimes in our partner’s offices. We partner with many of the world’s leading pharma companies so in return we are able to offer enviable career and development opportunities for our employees.

Home based in any European Countries

Permanent and full time role
Competitive Salary
Strong Work/Life Balance

To apply please send your most recent CV to vera.stellino@docsglobal.com