Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings
Produce data listings, summary tables, and graphics for interim and final analyses
Integrate data across studies within a project; test, document, review, and validate all programs according to department guidelines
Coordinate data transfer and/or programming standards with CROs and vendors; validate analysis datasets and TFLs from vendors
Collaborate with other Biometrics functions for all activities related to the analysis of clinical trial data
Responsible for the execution of ad-hoc requests, manuscripts, posters, and presentations.
Requirements
Minimum of 10 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math, or MA/MS with 8 years of experience
Expertise in SAS programming language, report generation, and standards for programming and validation
Experience with CDISC data standards required
Experience as a senior statistical programmer at a pharmaceutical or CRO working in an FDA-regulated environment
Experience with Clinical Study Reports and NDA submission
Therapeutic area- Rare Disease
Ability to work on multiple tasks simultaneously and meet project deadlines
Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
Benefits
Security and additional career opportunities of a global CRO
Supportive culture
Continuous training and close management
Professional development opportunities
Equal opportunity employer
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SAS programmingreport generationdata managementdata validationdata integrationCDISC data standardsstatistical programmingdata listingssummary tablesgraphics production
Soft skills
interpersonal skillsverbal communicationwritten communicationcollaborationtime managementmultitaskingteamworkproject managementattention to detailproblem-solving