Principal Statistical Programmer/Analyst Consultant

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage in the design of Case Report Forms (CRFs), assess databases, develop data management plans, and oversee data validation procedures, along with reviewing data listings;

• Generate data listings, summary tables, and graphical representations for both interim and final analyses;

• Combine data from various studies within a project. Test, document, review, and validate all programs in accordance with departmental standards;

• Manage data transfers and/or programming standards in collaboration with Contract Research Organizations (CROs) and vendors. Validate analysis datasets and Tables, Figures, and Listings (TFLs) provided by vendors;

• Work closely with other Biometrics functions for all tasks associated with the analysis of clinical trial data;

• Accountable for executing ad-hoc requests, manuscripts, posters, and presentations.

⛳️ Requirements

• A minimum of 10 years of experience in SAS programming within the pharmaceutical or biotechnology sectors, holding a BA/BS in computer science, statistics, or mathematics, or an MA/MS with 8 years of experience;

• Proficient in SAS programming language, report generation, and the standards required for programming and validation;

• Experience in the therapeutic area of Rare Diseases;

• Familiarity with CDISC data standards is mandatory;

• Previous experience as a senior statistical programmer within a pharmaceutical company or CRO in an FDA-regulated setting;

• Knowledge of Clinical Study Reports and NDA submissions;

• Capability to manage multiple tasks concurrently while adhering to project deadlines;

• Strong verbal and written communication skills, along with excellent interpersonal abilities for effective collaboration in a cross-functional team environment.

🏝️ Benefits

• ClinChoice fosters a supportive culture;

• Opportunities for professional development.