Senior Statistical Programmer - Germany
- Clinical Research, Clinical Project Manager, Clinical Services, Clinical Trials Manager / Administrator, Feasibility, Study Site Coordinator, Data Management / Statistics, Clinical Data Management, Statistics, Medical Affairs, Medical Advisor, Quality, QA / QC, Quality Validation Engineer
Summary of Job Responsibilities:
The Senior Statistical Programmer leads the programming activities for a trial, early phase project, indication, or publication activities. Develops and supports statistical
programming computer systems that are used in the production of statistical analysis plan (SAP)-planned tables, data listings, and graphs, integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles. If the programmer is delegated as a lead there may be additional responsibilities for monitoring and meeting assigned program milestones as well as leading a small team of statistical in-house or consultant programmers to accomplish tasks. Essential functions include creating systems that assist the Statistical Programming staff and Biostatistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications; developing systems to support electronic regulatory submissions; providing systems and support for clinical data management staff, clinical programmers, quality control (QC) staff, and biostatisticians; producing and supporting systems that extract data from the clinical database; and building analysis databases composed of SAS datasets.
The Senior Statistical Programmer must follow established standardized design and
programming procedures; provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities; and develop and maintain clinical processing work flow systems.
The Senior Statistical Programmer works on the Client's systems and under the Client's SOPs/processes. The Functional Service Provider (FSP) programmers support various projects across the portfolio, by augmenting the Client's current staff.
Qualifications and Experience:
Minimum Education: BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 5 years of SAS programming experience with clinical trial data.
Minimum Work Requirements: General knowledge of regulatory requirements and drug development process.
Skills: Excellent organizational skills and good verbal and written communication skills. Ability to work independently is required.
Compensation & Benefits
We offer a competitive salary-based package, along with bonus, comprehensive medical/healthcare insurance, plus a contributing pension.
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