Principal Programmer, Statistical Programming

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

📋 Description

• Collaborate with management to assign tasks effectively and monitor their progress.

• Deliver expert technical assistance to team members.

• Act as the project lead Statistical Programmer for clinical sub-teams.

• Utilize advanced SAS functionalities, including integration with software applications and operating system tools.

• Conduct quality control assessments of SAS code and outputs generated by other Statistical Programmers.

• Address intricate reporting challenges associated with clinical trials.

• Support daily operations and guarantee that study tasks are executed accurately and punctually.

• Interact with Statistical Programmers, Biostatisticians, Data Management, and other departments, frequently at Senior Management levels.

• Generate files, documents, and analyses necessary for electronic submissions in eCTD format, including ISS/ISE.

• Provide leadership ensuring adherence to Vertex SOPs and FDA/ICH/GCP regulations.

• Create, review, and endorse documentation that supports data analysis, reporting, and CDISC data submissions.

• Engage in cross-functional project management teams focused on SOPs, guidelines, process enhancements, system validation and acquisition, as well as integration of tools and technologies.

⛳️ Requirements

• Bachelor's degree in a scientific field.

• Typically requires 5+ years of relevant experience for candidates with a Master’s degree or above, or 8+ years for those with a Bachelor’s degree.

• Professional experience in biotechnology, pharmaceuticals, or a clinical research organization.

• Expertise in SAS language, procedures, and functions commonly employed in clinical trial reporting.

• Proficient in SAS Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.

• Intermediate understanding of CDISC standards.

• Intermediate knowledge of clinical trials.

• Experience with regulatory submissions.

• Strong written and verbal communication abilities.

• Familiarity with clinical development and medical data.

• Experience with eCTD submissions, including ISS/ISE.

• Understanding of Vertex SOPs and FDA/ICH/GCP regulations.

🏝️ Benefits

• Eligibility for annual bonuses.

• Annual equity awards.

• Overtime pay eligibility as per federal and state regulations.

• Comprehensive medical benefits.

• Dental coverage.

• Vision insurance.

• Generous paid time off policy.

• Company-wide shutdown for one week in both summer and winter.

• Educational assistance programs, including student loan repayment options.

• Commuting subsidies.

• Charitable donation matching.

• 401(k) plan.

• Flexible work arrangements available through Remote-Eligible Flex Designation.