Principal Statistical Programmer Consultant

Main Job Tasks and Responsibilities:

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;

Therapeutic area- Rare Disease;

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;

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.