Principal Statistical Programmer

Principal Statistical Programmer

Position Summary

We are seeking a highly experienced Principal Statistical Programmer to lead and support complex statistical programming activities across clinical studies, projects, portfolios, and standards initiatives. The ideal candidate will possess deep expertise in SAS programming, CDISC standards, regulatory submissions, and clinical trial reporting. This role requires strong technical leadership, stakeholder management, mentoring capabilities, and the ability to deliver high-quality programming solutions across multiple therapeutic areas.

Key Responsibilities

Lead and contribute to medium and high-complexity statistical programming deliverables across studies, projects, portfolios, and standards initiatives.

Develop, validate, and review clinical datasets, Tables, Listings, and Figures (TLFs) in compliance with CDISC and study standards.

Provide technical leadership and mentorship to statistical programmers, ensuring quality, consistency, and adherence to programming standards.

Collaborate with Statistical Programming Leads, Biostatisticians, Clinicians, Data Management teams, and global stakeholders to achieve study milestones and deliverables.

Support resource planning, project timelines, workload management, and quality oversight for programming activities.

Review, modify, and optimize existing codebases and standards to support study and portfolio requirements.

Participate in regulatory submission activities, including ISS, ISE, submission packages, and Regulatory Authority Questions (RTQs).

Ensure compliance with ICH guidelines, regulatory requirements, and industry best practices.

Maintain accurate documentation for programming deliverables, validation activities, and standards implementation.

Support continuous improvement initiatives, standards development, process optimization, and knowledge-sharing activities.

Manage multiple projects simultaneously while ensuring timely and high-quality delivery.

Act as a Subject Matter Expert (SME) for statistical programming and clinical data standards across therapeutic areas.

Required Qualifications

Bachelors or Masters degree in Statistics, Biostatistics, Biological Sciences, Information Technology, or a related field.

7+ years of experience in Statistical Programming within pharmaceutical, biotechnology, CRO, or regulatory environments.

Strong hands-on SAS programming experience.

Extensive experience developing and validating SDTM, ADaM, and TLF deliverables.

Strong understanding of CDISC standards and clinical trial data reporting requirements.

Experience supporting regulatory submissions, including ISS, ISE, submission packages, and RTQs.

Knowledge of ICH guidelines and regulatory requirements.

Experience across at least three therapeutic areas, including Oncology.

Proven experience mentoring programmers and leading programming deliverables.

Strong analytical, problem-solving, communication, and stakeholder management skills.

Ability to manage multiple projects and work independently with minimal oversight.

Familiarity with Agile methodologies and ways of working.

Preferred Qualifications

Experience with R Programming.

Experience supporting portfolio-level standards and automation initiatives.

Prior experience in a Principal or Lead Statistical Programming role.