Under the supervision of the Principal Statistician, this position will provide programming support to clinical trials. Specifically provide programming support from CRFs design, data management to study report and publications. The Sr. Clinical Programmer will ensure quality and timely deliverables and compliance with company SOPs and health authority guidelines.
Duties and responsibilities may include, but are not limited to:
- Interface with data management, medical and statistical personnel to provide programming support for clinical development activities, including but not limited to data review and cleaning, creating outputs for clinical study reports, interim analysis, ad hoc analysis, manuscripts and presentations.
- Manage vendors and oversee the work delivered by CROs.
- Develop software solutions for regulatory or compliance issues related to SAS applications within Clinical Development.
- Familiarity with CDISC standards in the development of SDTM and ADaM datasets.
- Integrate clinical databases in support of SCS and SCE reporting requirements.
- Provide input in CRF design, edit check spec development and mock tables/listings/figures.
- Support programming effort for electronic regulatory submissions, as required.
- Create, validate and maintain global SAS macros to increase programming efficiency when necessary.
- Master’s Degree in Statistics, Computer Science, or related discipline.
- Five to ten years’ experience with SAS programming in the pharmaceutical industry, phase I-III clinical studies preferred.
- SAS Macro programming experience and clinical database management systems programming required..
- Oncology experience preferred.
- Prior people/project management experience is a plus.
- Ability in accuracy and attention to detail. Strong analytical and problem-solving abilities.
- Understanding of the conceptual basis for clinical programming conventions, standards and processes.
- Knowledge of regulatory and statistical issues associated with clinical trial databases.
- Familiarity with CDISC implementation.
CTI BioPharma - 22 months ago
Cell Therapeutics, Inc. (Cell Therapeutics) develops, acquires and commercializes treatments for cancer. The Company’s research,...