Senior Analyst/Programmer

Katalyst Healthcares & Life Sciences

Responsibilities:

Overseeing SAS programming activities from varying aspects: programming, statistical and clinical
Create, manage, and maintain the SAS programming algorithm for the clinical study database and data analysis
Peer review the submission packages and contribute to the input of SAP and mock TFLs
Perform ad hoc analyses to support Phase I to IV clinical trials and medical publications
Maintain relationships with internal and external customers and vendors
Mentor up and coming junior programmers and analysts
Tracking projects against goals and submit status reports to project management

Requirements:

Bachelor's or advanced degree in statistics, biostatistics, computer science or related fields
4 to 6 years' experience in the pharma/biotech industry
Advanced SAS programming skills (e.g, SAS SQL, SAS Macro, SAS/STAT, SAS/GRAPH, etc.) with clinical trial data
Advanced knowledge in industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
Experience in handling and processing upstream data, e.g., EDC, eDT, SDTM, and in providing outputs to meet downstream requirements, e.g., ADaM, define.xml and TFLs