Currently looking for qualified candidates at all levels to be part of an exciting team in the following therapeutic areas: HIV, Cardiovascular, Liver Disease, Oncology, and Respiratory/Inflammation.
Candidates will be expected to have familiarity/expertise in the production/validation of SDTM/ ADaM datasets and Tables, Listings, Figures as well as the ability to utilize global macros as appropriate for Phase 1-3 studies.
Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
Assesses the quality and consistency of analysis data and performs cross-study analyses.
Uses internal macros or writes SAS® macros to automate study deliverables.
Works as a primary programmer for multiple Phase 1-4 studies.
Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies.
Independently develops analysis specification & programs.
Identifies potential issues in study documentation and proposes solutions.
Contributes to strategic initiatives.
Assist with study and systems audits by GSI Compliance Group and external bodies, and respond to audit questions and findings
Promote and communicate awareness of programming and the role of the Biometrics department (internal/external; scientific/process)
Excellent verbal and written communication skills and interpersonal skills are required.
Has thorough knowledge of clinical trial study design and electronic data submission requirements.
Must be able to work independently on multiple concurrent projects.