Principal Programmer – United States & Canada
The Principal Statistical Programmer is responsible for creating programs to develop, validate, and document datasets, tables, listings, and figures related to the compounds being studied. The focus for this position will be on support of clinical development and post-marketing activities. Programming expertise is needed for data review and to support scientific publications and other requests for medical affairs. The Principal Statistical Programmer must have extensive experience in the use of SAS software for analysis of clinical trial data and thorough knowledge of CDISC standards. Oversight of vendor programming may also be required. At least 8 years’ experience in SAS programming on clinical trials is required
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Function as lead programmer for one or more indications of compounds under study
- Provides programming of tables, listings, figures to support the needs of internal monitoring and analysis, including graphical displays for scientific publications as needed.
- Leads and supports programming for clinical study reports, as needed, including oversight of statistical programming for outsourced trials. Meets regularly with CRO counterparts. Attends clinical study team meetings as needed.
- Provides review of eCRFs, annotated CRFs, data management plan, edit check specifications, and statistical analysis plan, with a view to ensuring that data required for specified analyses will be collected, clean, and can be appropriately analyzed.
- In collaboration with data management, may provide specialty SAS programming for data management including customized line listings to support review of clinical trial data.
- Ensures that study documentation is maintained to the standard required according to SOPs and acceptable for audit.
- Ability to communicate technical concepts to others.
- All other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
- B.S. (M.S. preferred) in Biostatistics, Computer Science or related field with at least 8 years’ experience in the pharmaceutical industry, with relevant experience in the analysis of clinical trial data or an equivalent combination of education and experience.
- Incumbent must have SAS programming experience to support these activities.
- Experience with SAS/Graph and/or providing quality graphics for scientific publications.
- Understanding of 21CFR Part 11 standards.
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com