Biostatistician/SAS Programmer

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

📋 Description

• Collaborate with cross-functional teams to design and evaluate clinical trials and observational studies.

• Create and validate SAS programs for data handling, statistical analysis, and report generation.

• Develop and review statistical analysis plans, study protocols, and data specifications.

• Execute quality control checks on datasets, tables, listings, and figures.

• Perform statistical analyses using SAS and interpret results for study, quality, production, and FDA-related goals.

• Offer statistical consultation and programming assistance to Clinical Research, Quality, Production, and other cross-functional teams.

• Aid in FDA remediation, regulatory submissions, agency responses, and related documentation.

• Present statistical outcomes and clarify analytical methods to both internal and external stakeholders.

• Stay updated on current statistical methodologies, SAS programming practices, and best approaches for data quality and reproducibility.

⛳️ Requirements

• A Master’s or PhD in Biostatistics, Statistics, or a related discipline.

• A minimum of 3 years of professional experience in biostatistics or statistics.

• Strong expertise in SAS programming, including Base, Macro, SQL, and statistical procedures.

• Experience with clinical trial data and regulatory submissions, particularly with CDISC SDTM/ADaM standards.

• Understanding of regression, survival analysis, and mixed models.

• Familiarity with R or STATA is advantageous.

• Excellent problem-solving, communication, and teamwork abilities.

• Capacity to handle multiple projects and adhere to tight deadlines with meticulous attention to detail.

🏝️ Benefits

• Fully remote work arrangement.

• Reasonable accommodations for qualified individuals with disabilities in job application procedures.