Senior / Principal Statistical Programmer, Clinical Development Data Services, R&D, Orion Corporation

Orion Pharma•Boston, MA

4d•$100,000 - $180,000•Hybrid

About The Position

As a Senior / Principal Statistical Programmer in a growing oncology-focused Data Sciences function, you are responsible for the development, validation, and delivery of clinical trial datasets, statistical outputs, and regulatory submission packages that support oncology drug development programs. This role contributes to the successful execution of Phase I–III clinical studies through high-quality programming, data standardization, and submission-ready deliverables in compliance with CDISC standards and applicable regulatory requirements.

Requirements

Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative field.
5+ years of statistical programming experience within the pharmaceutical or biotechnology industry, oncology preferred.
Strong programming skills in SAS (base, macro, SQL, STAT, GRAPH); knowledge of R/Python is an advantage.
Solid understanding of CDISC standards, controlled terminology, define.xml, and submission requirements.
Hands-on experience preparing regulatory submission packages (define.xml, Pinnacle 21, reviewer guides) for FDA/EMA.
Demonstrated interest in applying automation and AI-enabled solutions to improve programming efficiency and data quality.
Strong attention to detail with excellent analytical, problem-solving, and documentation skills.

Nice To Haves

knowledge of R/Python is an advantage

Responsibilities

Independently lead programming activities of moderate to high complexity while ensuring quality, accuracy, and adherence to timelines.
Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards, study specifications, and regulatory requirements.
Program, validate, and deliver Tables, Listings, and Figures (TLFs) for clinical study reports, interim analyses, and regulatory submissions.
Perform quality control (QC) reviews and ensure traceability, reproducibility, and compliance of programming deliverables.
Contribute to the development of dataset specifications, define.xml files, reviewer guides, and other submission documentation.
Support preparation and delivery of electronic submission packages for global regulatory agencies, including FDA and EMA.
Collaborate with Biostatisticians on implementation of Statistical Analysis Plans (SAPs) and interpretation of programming requirements.
Support data review, data cleaning, discrepancy management, and database lock activities throughout the study lifecycle.
Work closely with Data Management and external vendors to ensure consistency of standards and data quality.
Ensure compliance with SOPs, GxP requirements, CDISC standards, and industry best practices.
Drive adoption of innovative programming approaches and AI-assisted workflows to improve efficiency, quality, and scalability of clinical trial deliverables.
Contribute to programming standards, macros, and process improvements that enhance efficiency and quality.
Provide technical guidance and mentoring to junior programmers when appropriate.