Senior/Principal Statistical Programmer - Submissions Toledo
A specialist CRO is looking to hire a Senior Programmer to join them on a permanent basis. Working across clinical and non-clinical studies, you will support regulatory submission activities; produce and validate datasets and outputs whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines is required. You will produce, review and update complex dataset specifications (including efficacy); create and debug complex macros; review Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year.
Responsibilities
1. Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
2. Become independent technical expert
3. Program complex non-efficacy outputs/figures
4. Perform Senior Review and Deliver QC of non-statistical output
5. Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
6. Validate and perform User Acceptance Testing (UAT) on standard macros
7. Identify macros requirements, communicate and perform training
8. Create, QC and update complex dataset specifications (including efficacy) for single/multiple studies, ISS/ISEs, etc.
9. Implement and coordinate development and maintenance of standard specifications
10. Be an SDTM and ADaM expert providing consultancy, advice and training
11. Be a CRT expert providing consultancy, advice and training
12. Develop archiving systems and processes
13. Act as a Lead programmer on multiple studies and projects, ensuring quality and timely delivery
14. Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
15. Responsible for study level resources
16. Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
17. Persuade stakeholders to follow best practice within a trial
18. Develop and deliver company-wide training as and when required
19. Create, review and update processes and SOPs
Qualifications
1. Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
2. SAS Programming Experience within the pharmaceutical industry
3. Good awareness of clinical trial design and implementation
4. Experience of regulatory submissions and associated industry guidance
5. Familiarity with GCP and regulatory requirements
6. Knowledge of SDTM and ADaM CDISC standards
For additional information and a confidential discussion, please apply now with an updated CV.
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