4 of 4 CDISC Jobs in Berkshire

listings) when not provided by CRO. Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format. Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group. Works closely with clinical study teams to plans … e.g. GCP, ICH). • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills. • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM). • Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent). • Proven ability to work More ❯

with a wide range of clients to lead Phase II & III studies, program statistical analyses/reports, analyze datasets, tables, figures (or graphs), listings (TFLs), with an emphasis on CDISC ADaM programming. Our team works remotely across multiple countries which provides the flexibility to adjust your schedule as needed. With much collaboration across regions, we still have that small company … experience successfully performing the role of Statistical Programmer, in the clinical research industry Experience leading Phase II and/or Phase III studies Experience creating and validating analysis datasets (CDISC ADaM standard preferred), and Tables, Listings, and Figures (TLF) Strong SAS programming experience Pinnacle 21 experience is strongly preferred Professional leadership skills coupled with exceptional communication skills Bachelor's degree More ❯

clinical trial results into value dossier and regulatory submission packages Lead development of statistical programs using SAS for regulatory and non-regulatory submissions (pre-defined and post-hoc) Implement CDISC standards as required for project deliverables Conduct QC programming for descriptive and complex studies in RWD Contribute to writing study reports and use of visualization tools for reporting and data More ❯

and overall quality in a client-facing capacity (project leadership track only) Advanced/expert-level of project leadership/technical track, respectively, working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation Strong working knowledge of the types of risks associated with a study and the impact on key parameters, such as study timelines More ❯