Contract

Principal Statistical Programmer

Posted 1 year ago by DNA | Life Sciences
100% Home-Based

Job Description

This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas such as oncology, cardiovascular, respiratory, neurological, diabetes, rare diseases, pain, immunology etc. Your expertise has a direct impact on improving the health and lives of thousands of patients around the globe every day.

Your work location can be 100% home-based anywhere in the EMEA mentioned on this ad – or, if you prefer, in any of my clients offices.

 

What my client offer!

  • Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
  • Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
  • A genuine work life balance
  • Flexibility in working hours
  • A thorough onboarding with support from your personal mentor
  • Excellent training and career development opportunities, as well as support with advancing your individual education
  • Strong support from your Line Manager and your team, as well as a vast amount of colleauges

Your Responsibilities

  • Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
  • Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform quality control reviews of SDTM, ADaMs and TFLs
  • Produce and/or define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
  • Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets, and contribute to the development of company and client standards
  • Review SAPs and TFL shells from a programming perspective for studies, and advise on the development of complex TFL shells from a programming perspective
  • Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs as well as Study Lead processes, while ensuring adherence to department practices and processes
  • Facilitate advanced technical expertise
  • Present and share knowledge at department meetings
  • Respond to QA and client audits and represent the department in all types of audits
  • Contribute your expertise to proposal activities and bid defenses
  • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

Job Requirements

  • Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  • In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming
  • Profound professional experience as a lead / principal statistical programmer working on complex studies within a biotech, CRO or pharmaceutical company
  • Expert knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an excellent understanding of the roles and responsibilities ofall related disciplines, e.g. Biostatistics and Clinical Data Management
  • Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs
  • Profound knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer’s Guide and submission standards
  • Excellent organizational, time management and project management skills with demonstrated leadership skills
  • Outstanding problem solving and decision making skills, coupled with a proactive approach – anticipating issues and working to ensure they are avoided or resolved as quickly as possible
  • An autonomous, collaborative work style, a curious mind and a keen attention to detail
  • Business fluency in English – both verbal and written