Beschreibung
Description
- Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent).
- Is the scientific lead for programming expertise liaising with Biometrician and statistical scientific counterparts within the team, across multiple clinical trials.
- Leads the full execution of final production output generation (tables, listings and graphics) for clinical trials.
- In conjunction with the Biometrician/Statistical Scientist, develop study-level programming standards and ensure compliance with project-level/company standards.
- Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRF and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities.
- Responsible for programming (according to specifications) analysis datasets, pooled datasets, listings, tables, and figures for Phase I-IV clinical trials and for SCS and SCE with high quality and within milestones.
- Maintain QC compliance and responsible for trial records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality deliverables.
- Review planning of edit checks; assist non-standard, complex data validation programming as needed according to agreed plans for the clinical trial.
- Assume the role of subject matter expert/trial domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance.
- Provide input on process improvement initiatives and participate in non-clinical project activities.
- Maintain up-to-date knowledge of programming software (eg SAS/R/Splus).
- Provide programming expertise in developing/selecting/modifying basic/intermediate MACROs for reporting standards.
- Problem solving and solution oriented; programming representation in the Clinical Trial Team and IIS project team.
Experience Requirement:
Michael Bailey International is acting as an Employment Business in relation to this vacancy.