Senior SAS Programmer

3 weeks ago

Maidenhead, Windsor and Maidenhead, United Kingdom BTA Full time

At BTA, we are seeking a highly skilled Senior SAS Programmer to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

As a Senior SAS Programmer in our sponsor-dedicated Flexible Solutions business unit, you will be central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative, and global top pharmaceutical companies. You will have the opportunity to lead studies through various phases of the clinical development plan and support submissions, regulatory questions, publications, as well as ad hoc and post hoc requests.

In this role, you will develop and validate SAS programs for data presentations and analyses, and provide programming support to your multidisciplinary global project team. This position allows you to participate in the development of innovative Oncology drugs.

Key responsibilities include:

  • Reviewing SAPs and TFL shells from a programming perspective
  • Advising on the development of complex TFL shells from a programming perspective
  • Developing and/or leading the development of complex specifications for SDTMs and ADaM datasets
  • Developing and maintaining SAS programs to create SDTM and ADaM datasets and TFLs, and performing quality control of SDTM, ADaMs, and TFLs
  • Producing/defining XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTMs and ADaMs
  • Responding to QA and client audits and supporting qualification audits
  • Identifying and proposing innovative ways to improve the efficiency, quality, and productivity of our clinical statistical programming business
  • Maintaining awareness of industry standards, global regulatory requirements, internal guidelines, and Standard Operating Procedures (SOPs)

Requirements include:

  • 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 for clinical trials
  • Solid professional experience as a statistical programmer within a biotech, CRO, or pharmaceutical company
  • Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
  • Proven professional experience with SDTMs, ADaM datasets (safety and efficacy), and TFLs
  • Solid knowledge of CDISC standards
  • Prior experience working on Oncology data (safety and efficacy) and/or on vaccine trials
  • Submission experience is ideal
  • Strong organizational skills, an autonomous and collaborative work style, a curious mind, and a keen attention to detail
  • Business fluency in English - both spoken and written - is a must

At BTA, we are committed to diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

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