Ocugen · 1 week ago
Principal Statistical Programmer
Malvern, PA
Full-time
Onsite
Lead/Staff
8+ years expOcugen is a company focused on clinical trial data analysis and regulatory submissions, seeking a Principal Statistical Programmer to lead programming activities. The role involves overseeing programming deliverables, ensuring compliance with regulatory standards, and mentoring junior programmers.
BiopharmaBiotechnologyHealth Care
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
Qualification
Required
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
Preferred
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
Company
Ocugen
Ocugen is a biotechnology company that develops novel gene and cell therapies to improve health and patient outcomes.
51-200 employees
H1B Sponsorship
Ocugen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$291.5MKey Investors
Janus Henderson InvestorsAvenue Capital Group
2025-08-08Post Ipo Equity· $20M
2024-11-07Post Ipo Debt· $30M
2024-07-31Post Ipo Equity· $35M
Leadership Team
Shankar Musunuri
Chairman, CEO & Co-Founder
Arun Upadhyay
Chief Scientific Officer
Recent News
2026-01-13
2026-01-11
Company data provided by crunchbase