Role: Senior Programmer II
Day Rate: Up to 520
Skills: Must have GMA experience - programming activities post registration, medical evidence, epidemiology studies would be a significant advantage.
Start Date: ASAP
The Senior Programmer is a delivery focused role responsible for programming deliverables with quality and timeliness, following established standards and processes. This position requires high technical skills and thorough industry knowledge to independently perform the programming tasks while using judgement about seeking guidance in complex situations. They can be responsible for leading the programming deliveries of clinical studies or small to medium sized clinical projects and can lead cross-functional teams to deliver continuous improvement
As a member of B&I Programming, collaborates with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:
-Data submission strategy (e.g., managing legacy data, pooling data)
-Responses to regulatory agency queries
-Tables Figures and Listings (TFLs)
-Development Safety Update Reports (DSURs)
-Periodic Benefit-Risk Evaluation Reports (PBRERs)
-Investigators brochures (IBs)
-Office of Scientific Investigations (OSI) data sets and listings
-Regulatory and/or Payer submission related analysis data sets and/or TFLs
-Associated quality and process documentation as per applicable business processes
-Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
-Pharmacokinetics/pharmacodynamics data preparation and analysis
-Manipulating and analyzing adjudicated data
-Data preparation and analysis for Global Medical Affairs work
-Clinical Trial Transparency deliverables (data de-identification, results posting files)
-Timely upload of documents to eTMF
Produce and maintain the technical database standards and Programming Specification documents.
Contributes to and/or lead aspects of the provision of technical consulting expertise to external partners in relation to the specifications and delivery of the SDTM and ADaM databases by these partners.
Contributes to and/or lead the development of best practice to improve quality, efficiency and effectiveness.
Identify opportunities to improve the methodology and provide practical solutions for problems.
BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
Advanced SAS programming knowledge and experience.
Knowledge of database set-up and report publishing requirements.
Advanced knowledge of technical and regulatory requirements related to the role.
Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.
Advanced knowledge and experience of clinical drug development or healthcare.
Develop and deliver training.
Able to demonstrate team working and role leadership skills appropriate to level.
Please apply or send your CV to email@example.com
- Agency: Cpl Life Sciences
- Contact: Luke Sandilands
- Reference: JO-2201-483358
Website: Cpl Life Sciences
- Posted: 13th January 2022
- Expires: 10th February 2022