Site Name: UK – Hertfordshire – Stevenage
Posted Date: Jun 29 2023
Principal Programming Lead – Data Conversion and Standards
We are currently hiring a Data Programming Lead; in this role you will build the SDTM in-house programming capability within Global Clinical Operations. The objective of the role is to be the programming and technical expert to build study specific and standard programming required for delivery and regulatory submission.
- Provide innovative solutions, developing and delivering a quality data conversion process as well as ensure operational delivery for oncology portfolio and expert knowledge in defensive programming techniques.
- Responsible for the development, validation, and review of study & standard programs/macros (Including SAS, PL/SQL.SPOTFIRE, R-Programming, Python) that support standard and study-level conversion of clinical trial data.
- Responsible for review development and validation of CDASH and SDTM Mapping to support management of data standards. Review and development of aCRF, SDRG, Pinnacle 21 annotation and define xml for standards or specific studies.
- Lead the Requirement gathering, development of specifications, Validation plans and performing end to end validation of Standard/Study macros.
- Support the programmers in trouble shooting and debugging of complex standard and study programs/macros.
- Act as a technical owner and/or reviewer/ultimate approver for tools and programs developed in SDTM Programming group.
- Knowledge on regulatory submissions (JPMA/PMDA) and hands-on knowledge on programming data conversions.
- Contributes to GSKs compliance to external data standards, mandates and reviews industry data standards proposals/changes and provisions feedback.
- Develops standards in-line with business demand e.g., CDISC SDTM dataset, Controlled Terminology (CT), Value level definition and metadata (VLD/VLM)
- Identify any areas for improvement in the existing process and bring futuristic innovative solutions.
Closing Date for Applications: 13th July 2023 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Qualifications & Skills:
- BS in Computer/Math/Statistics/Applied sciences
- Extensive programming experience
- Significant experience in delivering quality data conversion delivery within the organization
- Understanding different data conversion requirements across different TA and assets
- Extensive knowledge of the drug development process and a working knowledge of GCP.
- Experience with oncology portfolio delivery
- Prior knowledge of SDTM conversion and good understanding of Data Management and the study build process
- Experience working on GSK Rx SDTM SAS in-house delivery model is preferred.
- MS in Computer/Math/Statistics/Applied science
- Experience performing data conversion on large phase 3 oncology studies.
- Experience converting structured and unstructured data from various sources including RAVE/InForm/Veeva as per GSK standards.
- Experience with CRF automation process for SDTM annotations.
- Experience in the co-ordination of SDTM review on outsourced studies and understanding of SDTM harmonization for pooled analysis.
- Experience in collecting the Project Management Reports.
- Experience in handling end to end studies (CDM To Submission) from the Project Management perspective will be an added advantage.