Job Description

🚀 We’re Hiring: Senior Statistical Programmer (Bioinformatics)

📍 Location: Rockville, MD (Corporate Headquarters)

At Kolon TissueGene, Inc. , we’re advancing science to transform lives. Our Bioinformatics team is seeking a Senior Statistical Programmer —a pivotal role in shaping high-quality statistical analyses for clinical trials and publications.

This isn’t just about coding—it’s about ensuring scientific integrity. You’ll validate vendor work, support regulatory submissions, and collaborate across clinical, regulatory, and data science teams to deliver analyses that meet the highest industry standards.

What You’ll Do

• Lead and validate statistical programming deliverables for multiple Phase I–IV clinical trials.
• Review or generate SDTM/ADaM specifications and datasets.
• Create and validate analysis outputs for abstracts, publications, and regulatory submissions.
• Collaborate with cross-functional teams and external vendors to ensure quality, timeliness, and compliance.
• Apply a range of statistical techniques—from regression to survival analysis—while aligning deliverables to project objectives.

What You Bring

• Master’s degree in Statistics, Biostatistics, Data Science, or related field.
• 5+ years in statistical programming with SAS, including regulatory submission experience.
• Deep understanding of CDISC standards (SDTM, ADaM, CDASH) and regulatory guidelines (ICH E3/E6/E9).
• Expertise in statistical methods such as regression, hypothesis testing, and missing data analysis.
• Strong project management skills with the ability to juggle multiple priorities.
• Clear, collaborative communicator who thrives in cross-functional settings.

🌍 About Us

Kolon TissueGene, Inc. is a pioneering biopharmaceutical company focused on advancing regenerative medicine through innovative cell and gene therapies. Our lead product, TG-C , is a clinical-stage cell therapy designed to treat osteoarthritis of the knee — targeting not just pain relief, but disease modification.

As we prepare for a pivotal U.S. launch, we are building a mission-driven team to shape the future of biotech — and improve the quality of life for patients worldwide.

✨ Benefits Highlights :

• Onsite yet Flexible work schedules
• Premium-free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• Long-term incentive bonuses
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities
• Visa sponsorship available for qualified candidates

👥 Equal Opportunity Employer

Kolon TissueGene, Inc. is proud to be an equal opportunity employer . We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

📩 Apply today to shape the future of regenerative medicine with precision, rigor, and purpose .

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