Clinical Biostatistics Contractor (10-month contract)

Ascidian Therapeutics•Boston, MA

About The Position

Ascidian is redefining the treatment of disease by rewriting RNA. Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. We were inspired by ocean creatures, called Ascidians, who are primordial ancestors of vertebrates. To grow from larvae to adults, ascidians re-engineer their transcriptome through RNA editing via trans-splicing and alternative splicing. In our Brighton/Boston labs, RNA biology meets today's cutting-edge genomics, computational biology, and deep-sequencing technologies to create a new class of medicines that address the underlying causes of disease. We welcome you to come join our vibrant team and help us lead the way into a new gene therapy era. Your Role We are seeking an experienced Clinical Biostatistician to provide both strategic statistical leadership and hands-on operational execution on our clinical development program, with primary focus on Phase 1–2 trials and demonstrated experience supporting late-stage (Phase 2/3 or registrational) programs. This role is designed for an independent, highly experienced biostatistician who can operate with minimal oversight, exercise strong scientific judgment, own execution and serve as a strategic partner to Clinical Development, Regulatory, and Program Leadership.

Requirements

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

Nice To Haves

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

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