Kolon TissueGene, Inc. · 3 hours ago
Associate Director- Bioinformatics
Rockville, MD
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expKolon TissueGene, Inc. is seeking an Associate Director, Bioinformatics to provide hands-on technical and operational leadership supporting clinical development programs. This role is responsible for managing bioinformatics, biostatistics, and statistical programming activities that enable high-quality, compliant clinical data generation and analysis.
BiotechnologyHealth CareMedicalPharmaceutical
Hiring Manager
Vaidehi Hussain
Responsibilities
Lead and deliver bioinformatics, biostatistics, and statistical programming activities for clinical studies
Support clinical trial design, data analysis, interpretation, and reporting
Participate in protocol development, including statistical analysis plans
Contribute to scientific publications, abstracts, and presentations
Oversee day-to-day bioinformatics, data management, and statistical programming operations
Mentor, coach, and develop junior staff within the Bioinformatics function
Ensure timely, accurate, and high-quality deliverables aligned with clinical development timelines
Partner with Clinical, Medical, Regulatory, and external vendors to support clinical development objectives
Assist with vendor oversight and coordination of external biometrics resources
Support regulatory submissions and participate in regulatory meetings as needed
Ensure compliance with internal procedures, CDISC standards, and applicable regulatory requirements
Promote data integrity, documentation quality, and inspection readiness across all deliverables
Qualification
Required
Master's degree in Statistics, Biostatistics, Bioinformatics, or a related scientific discipline
Minimum of 10 years of relevant experience in pharmaceutical, biotechnology, or clinical research environments
Demonstrated hands-on experience with clinical trial data analysis and reporting
Proficiency in SAS and other statistical or data science tools
Proven experience mentoring and developing junior professionals
Strong technical expertise in bioinformatics and statistical methodologies
Excellent written and verbal communication skills
Ability to work independently and collaboratively in a multidisciplinary environment
Strong organizational, analytical, and problem-solving skills
Commitment to continuous learning and professional development
On-site position with up to approximately 20% travel
Extensive computer and keyboard use involving repetitive motion
Regular telephone and in-person communication
Ability to lift up to 25 pounds, with or without reasonable accommodation
Company
Kolon TissueGene, Inc.
Kolon TissueGene, Inc. is a biotechnology company developing advanced cell therapies to target various orthopedic diseases and degenerative disorders.
11-50 employees
H1B Sponsorship
Kolon TissueGene, Inc. 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 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$124.73M2024-06-05Post Ipo Equity· $35M
2023-05-15Post Ipo Equity· $30M
2022-08-26Post Ipo Equity· $29.64M
Leadership Team
Sun Jin Kim
Chief Medical Officer
Recent News
2025-02-16
Company data provided by crunchbase