Principal Statistical Programmer

OCUGEN OPCO INC•East Whiteland Township, PA

4d•Onsite

About The Position

The Principal Programmer will lead and oversee programming activities for clinical trial data analysis and global regulatory submissions. This role requires advanced expertise in CDISC standards (SDTM, ADaM), submission deliverables (define.xml, CSDRG, aCRF), and generation of TLFs in compliance with agency requirements (FDA, PMDA, EMA, NMPA/China, and other global authorities). The position involves strategic technical leadership, mentoring junior programmers, and ensuring submission-ready deliverables that meet stringent regulatory standards.

Requirements

Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
8+ years of SAS programming experience in clinical trials, with at least 3+ years in a lead or principal role.
Proven expertise in CDISC standards (SDTM, ADaM) and regulatory submission deliverables (define.xml, CSDRG, aCRF, ADRG).
Strong experience preparing submission-ready datasets and documentation for FDA, PMDA, EMA, NMPA/China, and other global agencies.
Proficient in SAS (Base, Macro, Stat, Graph); experience with R or Python is a plus.
In-depth understanding of clinical trial design, statistical principles, and regulatory requirements for electronic submissions.
Excellent leadership, communication, and problem-solving skills; ability to manage multiple priorities in a fast-paced environment.
Familiarity with TLF generation, controlled terminology, and validation tools for CRT compliance.
SAS certification preferred; experience with automation and programming efficiency tools is a plus.

Nice To Haves

Knowledge of data standards governance and emerging regulatory trends.
Experience with define.xml v2.0, Pinnacle 21 validation, and submission compliance checks.
Ability to lead cross-functional programming teams and interface with CROs and regulatory authorities.

Responsibilities

Set and own the statistical programming strategy across multiple clinical studies and global regulatory submissions.
Provide oversight of SDTM, ADaM, and analysis programming to ensure consistency, quality, and inspection readiness.
Lead and be accountable for programming deliverables supporting clinical study reports and regulatory filings, including Tables, Listings, and Figures (TLFs).
Serve as the accountable programming lead for submission deliverables, including define.xml, annotated CRFs (aCRF), CSDRG, ADRG, and eCRT datasets.
Ensure compliance with CDISC standards, GCP, internal SOPs, and global regulatory requirements.
Act as a senior subject matter expert for FDA, EMA, PMDA, NMPA (China), and other regulatory agencies.
Oversee portfolio-level timelines, resourcing, and delivery standards; proactively manage risks, dependencies, and escalations.
Partner closely with Biostatistics, Data Management, Regulatory, and Medical Writing leadership to align scope, sequencing, and submission readiness.
Establish and enforce programming quality standards, governance processes, and best practices across internal teams and CROs.
Lead, develop, and mentor statistical programming staff; ensure effective review, coaching, and technical stewardship.
Drive continuous improvement through process optimization, automation, and scalable programming solutions.