Job Reference: J5637173
Status: Open to Applications
We are currently looking for a Senior/Principal Programmer to join a leading Biopharmaceutical company based in the Oxfordshire area. As the Senior/Principal Programmer you will be responsible for Clinical Development, Enterprise Data & Analytics, or QDS projects, ensuring all aspects of Programming activities supporting the success of those projects, including guidance, decision-making, and contributions to milestone planning and delivery, data and knowledge stewardship, and inspection readiness.
Key Duties and Responsibilities
1. Provide SAS programming leadership to internal and external study teams in the reporting of clinical trials data, regulatory submissions, safety updates and publications.
2. Develop and review dataset specification documentation, dataset programs and associated reporting programs (tables, figures and listings) while following the clinical study protocol and/or statistical analysis plan.
3. Develop expert knowledge of CDISC methodology, specifically SDTM and ADaM models.
4. Ensure quality control is preformed on all programs written and is adequately documented.
1. Substantial experience in the biotechnology and/or pharmaceuticals industries.
2. Substantial statistical and/or scientific programming experience in a life sciences environment using SAS (especially BASE, STAT, GRAPH), R, and/or other relevant programming languages.
3. Expertise in clinical data standards (e.g., CDASH, SDTM, ADaM) and their practical applications in clinical trials and preparing compliant regulatory submissions.
Interested in this job? Apply for this position now!
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
Sectors: IS&T, Life Sciences
Skills: IT Pharma - Computational - SAS, IT Pharma - Computational - Statistics, IT Pharma - Computational - ADAM, IT Pharma - Computational - SDTM