Job Summary
Responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures produced by programming vendors, for ad-hoc analyses, and to assist with data cleaning and query generation. Independently produces selected SDTM/ADaM files for analysis preparation and for validation of CRO CDISC work.
Responsibilities
• Provides SAS programming support to all clinical studies
• Manages programming CROs providing oversight and appropriate QC for programming deliverables
• Provides primary programming and QC support for any internally produced outputs
• Reviews and approve SAS programming instructions and CDISC/ADaM specifications
• Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming
• Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming
Education, Certifications, Experience
• Bachelor’s Degree equivalent with a minimum of 8 years of experience in SAS programming with at least 6 of those in a clinical research setting, including academic and/or industry experience in all phases of clinical research
• Excellent SAS programming skills including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL)
Required Skillset:
• Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 4 years of pharmaceutical experience
• Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements
• Knowledge of CDISC and ADaM dataset structures and requirements
• Knowledge of all aspects of clinical drug development (Phase 1-4)
• Experience working with and managing a CRO partner
• Excellent computer skills; strong verbal and written communication skills
• Ability to work well in a team environment as a contributor
• Open, engaging, and transparent work style
• Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment