Job description Posted 03 February 2022

Senior Programmer for Clinical Trials

IT

Working from home, UK

6 Month initial contract with the view to extend

Pay rate up to £70 per hour via Umbrella inside IR35



Who Are We - GSK?

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc , although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.


Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. Our values and expectations are at the heart of everything we do and form an important part of our culture:


  • Our values are Patient focus, Transparency, Respect, Integrity
  • Our expectations are Courage, Accountability, Development, Teamwork


Job Purpose:

This role is to support the programming activities across multiple ongoing studies in the project, working closely with the Study Lead Programmer(s) to report and provide programming oversight for study analyses. This may involve programming of ADaM datasets, TFLs and performing independent QC/oversight of programming deliverables produced by third parties.



Role responsibilities:

  • Plans and participates in programming/QC activities at a study level.
  • Reviews and provides input to study level documents such as the Protocol, SAP, OPS, CRF and QC Record. Author or co-author of programming specifications.
  • May represent programming function on study team.
  • Provides programming oversight to less experienced programmers.
  • Accountability for specific issues.
  • Supports study team on implementation of core and therapy standards.
  • Adheres to timelines set by the lead programmer to meet study team milestones.
  • Recognizes and identifies technical problems or data-related issues.
  • Identifies and recommends solutions to problems in a well-defined and focused manner; apply recommended solutions.
  • Proactively anticipates and addresses issues at study, system development level, with some guidance.
  • Awareness of project objectives and requirements with guidance (e.g. proactive data aggregation strategy, regulatory queries).


Candidate requirements:

Mandatory:

  • Understanding of clinical trial process.
  • Knowledge and experience in SDTM and ADaM standards.
  • Recognises and identifies data-related or SDTM mapping issues.
  • Ability to implement core and therapy data and display standards.
  • In-depth knowledge of SAS statistical software. Knowledge of SAS macro language and SAS graph.
  • Demonstrated experience in SAS programming activities at a study level, including development/testing/maintenance of programs to create or QC ADaM datasets and TFLs.
  • Ability to author programming specifications.
  • Adheres to timelines set by the lead programmer to meet study team milestones.
  • Effective verbal and written communication skills.
  • Able to explain routine technical issues to a non-technical audience.
  • Bachelors Degree or equivalent with proven applicable pharma experience.

 

Preferred:

  • Prior experience at GSK i.e. HARP (In-house reporting & analysis system) knowledge.
  • Experience of PK, virology and biomarker data.
  • Able to provide input into OPS (Output Programming Specification) document.
  • Provides technical expertise in specific technical processes or areas (e.g. reporting procedures/macros, graphics, data validation, data capture strategies).