Senior / Principal Statistical Programmer, Clinical Development Data Services

Orion

Senior Statistical Programmer managing the development, validation, and delivery of clinical trial datasets for oncology programs. Ensuring compliance with CDISC standards and regulatory requirements in a hybrid work environment.

Posted 7/10/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $100,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in statistical programming and regulatory submissions, with a strong focus on CDISC standards and quality control. Proven ability to lead programming activities, mentor junior staff, and implement innovative solutions to enhance efficiency in clinical trial deliverables.

Highest-signal resume keywords

SAS ProgrammingCDISC StandardsRegulatory SubmissionsStatistical Analysis PlansData Management

ATS Keywords

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Hard Skills

Statistical ProgrammingSAS (Base, Macro, SQL, STAT, GRAPH)RPythonQuality ControlData CleaningDiscrepancy ManagementDataset SpecificationsAutomationAI-Enabled Solutions

Soft Skills

Attention to DetailAnalytical SkillsProblem-SolvingDocumentation Skills

Tools & Technologies

Pinnacle 21Define.xmlReviewer Guides

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryOncologyGxP RequirementsSOPs

Tech Stack

Tools & technologies

PythonSQL

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Continuous learning opportunities
Impact millions of lives
Strong emphasis on teamwork
Low hierarchies
A culture where every voice is heard