Senior Statistical Analyst

ABOUT THE ROLE As a Senior Statistical Analyst within the Bioinformatics team at Kolon TissueGene, Inc., you will play a pivotal role in conducting and validating statistical analyses that underpin our clinical development programs. This position demands a rigorous command of statistical methodology and programming, combined with a commitment to data integrity, regulatory compliance, and cross-functional collaboration. You will work alongside internal teams and external vendors to ensure the highest standards of analytical quality across our clinical trials. This is a full-time, onsite (M-F) position in a laboratory/office environment, based in Rockville, MD. Hybrid schedule accommodations are not available at this time. KEY RESPONSIBILITIES • Statistical Analysis & Validation: Conduct and validate statistical analyses for clinical trials, ensuring the accuracy and integrity of data outputs generated in-house or by vendors. • Publications & Abstracts: Prepare analyses for scientific abstracts and peer-reviewed publications. • SOP & Regulatory Compliance: Develop and uphold SOPs in alignment with regulatory guidelines including ICH E3, E6, and E9; ensure adherence to CDISC, SDTM, and CDASH data standards. • Programming: Apply advanced SAS programming and develop standard macros and tools to support data analysis and reporting. • Statistical Methodology: Apply advanced methodologies including regression, hypothesis testing, multivariate analysis, survival analysis, logistic regression, and missing data analysis. • Cross-Functional Collaboration: Partner with clinical, regulatory, and commercial teams, as well as external vendors, to ensure high-quality analysis and programming outcomes. • Project Management: Manage multiple concurrent projects, aligning statistical activities with program objectives and timelines. • Strategic Planning: Interpret statistical results and actively participate in the strategic planning of analyses across the clinical development portfolio. • Innovation: Stay current with emerging developments in statistics and statistical programming, contributing new methods and tools to the team. WHAT WE'RE LOOKING FOR The ideal candidate combines deep statistical expertise with hands-on programming skill and a sharp eye for data quality. You thrive in regulated clinical environments, communicate complex findings clearly, and take initiative in improving how analyses are designed and executed. REQUIREMENTS • Master's degree in Statistics, Biostatistics, Data Science, or a related field • Minimum 5 years of experience in statistical analysis and programming, with proficiency in SAS and/or R • Demonstrated expertise across a range of statistical techniques and methodologies • Comprehensive knowledge of statistical programming processes, including development, review, and validation of database specifications and analysis outputs • Experience preparing analyses for abstracts and scientific publications • Working knowledge of regulatory guidelines (ICH E3, E6, E9) and data standards (CDISC, SDTM, CDASH) • Experience collaborating with cross-functional teams and external vendors • Demonstrated capability managing multiple projects and contributing to strategic planning of analyses • Excellent oral and written communication skills CORE COMPETENCIES • Advanced proficiency in SAS statistical programming • Strong statistical methodology knowledge: regression, hypothesis testing, multivariate, survival, logistic, and missing data analysis • Deep understanding of clinical trial design, sampling estimation, and statistical inference • Ability to manage multiple projects and prioritize effectively • Strong attention to detail, accuracy, and analytical quality • Clear communication and interpersonal skills for cross-functional collaboration • Initiative and adaptability to new technologies and process improvements • Commitment to compliance, integrity, and continuous professional development Physical Requirements • Must be able to push, pull, lift or carry up to 20 pounds occasionally. • Must be able to engage in at least 30 minutes of moderate-intensity physical activity. • Must be able to sit or stand for long periods. 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 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. If you require a reasonable accommodation to participate in the application or interview process—such as completing an application, submitting materials, or attending an interview—please contact us at [email protected]. All requests for accommodation will be handled confidentially and in accordance with applicable laws.