SAS Clinical Trial Consultant Job at Katalyst Healthcares & Life Sciences
Responsibilities:
- Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.
- SAS programming experience working with clinical trials data in the Pharmaceutical & Biotech industry. 2
- To perform the lead programming role, lead continuous improvement in the programming function's operating systems and provide consultancy across the function.
- SAS certifications (Base, Advanced, etc.) are highly desired. Be proficient in Base SAS programming (DATA step), SQL programming (i.e., use of SQL pass-through or PROC SQL), as well as the SAS Macro language for use in making code more efficient.
- Familiarity with programming to generate summary statistics (mean, median, etc.) and complex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis).
- CDISC data models a necessity, especially SDTM then
- Contribute to department process improvement including creating and testing standard SAS Macros, maintaining the required validation documentation. Provide consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements.
- Develop and provide Statistical Programmers with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer.
- Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g. Excel, Visual Basic, Word). Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical
- Practice, clinical data management, clinical/statistical reporting and regulatory submission requirements etc.
- Act as subject matter expert for internal and external quality audits and inspections.
- 3 and sponsor quality requirements, relevant ICH and regulatory authority standards, e.g. FDA 21 CFR Part 11, General Data Protection Regulation (GDPR).
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