Senior Analyst/Programmer

3 weeks ago


Trenton, United States CareerBuilder Full time

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

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