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Lead Clinical SAS Programmer
3 months ago
Responsibilities:
- Plan and manage programming activities across multiple studies to deliver all data analysis outputs to agreed timelines and quality, (e.g., analysis datasets, tables, figures and listings for regulatory submissions and publications).
- Oversee outsourced tasks to third party vendors to meet the agreed timelines, quality and budget requirements established for the project or study.
- Implement data standards within a function, or therapeutic area in accordance with industry standards
- Review and inputs in eCRF desigining.
- Collaborate effectively with internal and external teams to support and resolve the programming issues.
- Conducts appropriate validation requirements, according to SOPs, for each task undertaken.
- Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution.
- Writes and maintains programming specifications datasets and programs assigned datasets to industry standards. Handles dataset derivations and assignment.
- Programs TLFs, maximizes programming efficiency with use of biostatistical tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced.
- Develops an efficient programming strategy utilizing available tools and creation/ maintenance of project specific macros, ensures compliance with Good Programming Practice as per SOPs.
- Creates or performs quality control (QC) review of define xmls, SDTM and/ or ADaM reviewers guide (SDRG, ADRG).g
- Ensure CDISC standards in development of data deliverables.
- Build relationship with team members within and between functions
- Participate in project related discussion and encourage team members to continuously interact with cross-functional teams to improve quality of results within stipulated timelines;
- Develops and assists in maintenance of department softwares, templates, guidelines, SOPs, and systems.
Qualifications
Qualifications:
- Graduate in science/computers/engineering with minimum 6 to 8 years of experience
Additional Information
Excellent understanding of and experience with SAS/Base, SAS Graph, SAS Macro Facility (writing stored, project-specific Macros)
Working knowledge in ADaM / SDTM / TFLs programming
Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
Understaning data management principles for clincial trials and Medical research.
Knowledge and experience using ODS to produce output to various destinations
(Word, Excel, XML)
Global Regulatory framework
Basics of Quality, clinical research, Formulation Development, Manufacturing
