The Principal Statistical Programmer will be responsible for providing hands-on support and technical guidance on clinical project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. This individual will participate in departmental and cross functional technology development and process improvement initiatives.
- Effectively designs and codes SAS programs for assigned clinical projects(s), consistently meeting objectives of the study
- Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format
- Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards
- Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
- Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry
- Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives
- May conduct briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA) on assigned projects
- Performs tasks with minimal instruction from supervisor
- May supervise other statistical programming staff
- Bachelor's Degree in Biostatistics, Mathematics, Statistics, Computer Science, Life Science M.S. (or equivalent degree) and 8+ years of relevant work experience, or B.S. (or equivalent degree) and 10+ years of relevant pharmaceutical industry work experienceExperience writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create data sets, tables, figures, and listings reporting results of clinical trials for investigational medications
- Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE
- Experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Experience with the CDISC SDTM and AdaM models and transforming raw data into these standards
- Experience working with all types of safety data and coding dictionaries (MedDRA and WHODRL) commonly used by the pharmaceutical industry
- Experience working in a team environment providing technical leadership and solving clinical trial reporting problems of moderate to high complexity within budget and customary time line constraints while assuring high quality standards
- Skilled at performing quality control checks of SAS code and output produced by other Statistical Programmers
- Knowledgeable regarding software validation and system development life cycle concepts
Associated topics: .net, c c++, c++, c#, java, php, programming, python, software developer, sw
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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