Ascidian Therapeutics · 8 hours ago
Clinical Biostatistics Contractor (10-month contract)
Boston, MA
Contract
Onsite
Senior LevelAscidian Therapeutics is redefining the treatment of disease by rewriting RNA. They are seeking an experienced Clinical Biostatistician to provide strategic statistical leadership and hands-on operational execution on their clinical development program, focusing on Phase 1–2 trials.
BiotechnologyGeneticsMedicalNeuroscienceTherapeutics
Responsibilities
Serve as the statistical lead for assigned clinical studies and development programs
Provide expert input into clinical trial design, endpoints, and analysis strategies across Phase 1–2 trials
Independently develop and author Statistical Analysis Plans (SAPs) and contribute to protocol design
Provide substantial input in creating a pivotal study protocol
Anticipate statistical risks and proactively propose mitigation strategies
Actively participate as a core member of cross-functional program teams
Partner closely with Clinical Development, Regulatory Affairs, Data Management, and Clinical Operations
Lead data review discussions and support internal governance, program reviews, and executive decision-making
Communicate complex statistical concepts clearly to non-statistical stakeholders
Provide senior-level statistical input into regulatory documents, including:
Clinical Study Reports (CSRs)
Investigator’s Brochures (IBs)
IND / CTA submissions and amendments
Regulatory briefing packages and responses to health authority questions
Ensure all statistical deliverables align with ICH guidelines (e.g., ICH E9) and global regulatory expectations
Support regulatory interactions as needed, including advisory boards and agency meeting
Qualification
Required
PhD in Biostatistics, Statistics, or a related quantitative discipline
Significant industry experience supporting clinical trials, including Phase 1–2 studies
Demonstrated experience in late-stage clinical development (Phase 2/3 or registrational trials)
Proven track record of providing both strategic statistical leadership and hands-on operational execution
Ability to independently design studies, develop SAPs, perform or oversee analyses, and interpret results
Deep understanding of regulatory standards and submission requirements
Experience working effectively in matrixed, cross-functional biotech environments
Demonstrated highest integrity
Preferred
Experience in ophthalmology
Prior experience in small to mid-size biotech companies and familiarity with fast-paced and outcome-driven environments
Direct experience supporting regulatory submissions and health authority interaction
Track record of providing strategic statistical guidance beyond execution
Company
Ascidian Therapeutics
Ascidian Therapeutics is a biotechnology company that focuses on medical and clinical gene therapy.
Founded in 2020
11-50 employees
H1B Sponsorship
Ascidian Therapeutics 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 (1)
2024 (3)
Funding
Current Stage
Early StageTotal Funding
$90MKey Investors
Apple Tree Partners
2023-11-08Series A· $40M
2022-10-11Series A· $50M
2021-01-01Seed
Leadership Team
Michael Ehlers
Founder, President, and Chief Executive Officer
Recent News
Company data provided by crunchbase