Director / Senior Director, Biostatistics

Cartesian Therapeutics•Frederick, MD

23h•Remote

About The Position

Cartesian Therapeutics is seeking an experienced and strategically minded Director or Senior Director of Biostatistics to join our Clinical Development team. This is a senior individual contributor and people-management role with significant influence across all active clinical programs. Reporting to the Vice President of Clinical Development, this position provides statistical leadership from protocol design through data analysis, regulatory submission, and post-marketing planning. The successful candidate will serve as the internal statistical authority for Cartesian's portfolio, interface directly with regulatory agencies, oversee external statistical resources, and help shape the analytical strategy for our emerging in vivo CAR-T program. This role requires both technical depth and the ability to communicate complex statistical concepts clearly to clinical, regulatory, and executive stakeholders.

Requirements

Master's degree in Biostatistics or Statistics required.
Ph.D. in Biostatistics, Statistics, or a closely related field preferred.
Ph.D. candidates: minimum 5 years of pharmaceutical/biotech industry experience, including experience leading statistical activities on at least one Phase 2 or Phase 3 clinical trial.
Master's candidates: at least 10 years of pharmaceutical/biotech industry experience preferred with demonstrated progression to senior statistical leadership roles.
Direct experience authoring or reviewing SAPs for randomized controlled trials required; Phase 3 SAP experience strongly preferred.
Experience supporting DSMB or Data Safety Committees.
Demonstrated experience managing or directing CRO statisticians and/or external statistical consultants.
Familiarity with CDISC standards (SDTM, ADaM) and regulatory expectations for submission-ready datasets.
Prior experience contributing to FDA regulatory submissions (IND amendments, meeting packages, BLA/NDA modules) is strongly preferred.
Expert proficiency in SAS.
R or Python experience valued.
Working knowledge of clinical trial design methods including adaptive designs, group sequential methods, and Bayesian approaches.
Experience with mixed-effects models, repeated measures analyses, and handling of missing data (multiple imputation, sensitivity analyses) in the context of chronic disease clinical trials.
Familiarity with estimand framework (ICH E9(R1)) and its application to protocol and SAP development.
Ability to operate effectively as both a strategic thought partner and hands-on technical contributor in a small company environment.
Strong written and verbal communication skills; able to translate statistical concepts for clinical, regulatory, and executive audiences.
Collaborative and solution-oriented; comfortable managing multiple programs simultaneously in a fast-moving biotech setting.

Nice To Haves

Ph.D. in Biostatistics, Statistics, or a closely related field.

Responsibilities

Oversee and interact with the CRO data management and statistical group to ensure accuracy of final outputs for the Phase 3 AURORA study.
Lead or contribute to protocol amendments and statistical analysis plan (SAP) amendments as the study evolves, ensuring alignment with FDA SPA agreements and RMAT designation commitments.
Review and approve TLF (tables, listings, figures) shells generated by CRO to ensure consistency with the SAP, regulatory expectations, and clinical data review needs.
Serve as the primary internal statistical point of contact for DSMB support for the Phase 3 AURORA study.
Develop and finalize protocol amendments for the Phase 2 TRITON study, including revisions to objectives, endpoints, estimands, and statistical methodologies.
Author and maintain the SAP for the Phase 2 TRITON study, including specification of primary and secondary analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses.
Design and implement the interim analysis plan for the Phase 2 TRITON study, including interim sample size evaluation and pre-specified stopping boundaries.
Provide ongoing DSMB statistical support for the Phase 2 TRITON study.
Contribute to protocol amendments for the Phase 1/2 HELIOS study, including updates to safety monitoring frameworks, dose escalation rules, and preliminary efficacy evaluations in the pediatric population.
Support Safety Monitoring Committee (SMC) operations for the Phase 1/2 HELIOS study with appropriate statistical summaries and ad hoc analyses.
Partner with Clinical Development to define the statistical and clinical trial design strategy for Cartesian's planned in vivo CAR-T program.
Advise on Phase 1/2 study design, dose escalation frameworks, estimand strategy, and adaptive design considerations for the in vivo CAR-T program.
Contribute to pre-IND and Type B meeting packages as relevant statistical support for the in vivo CAR-T program.
Collaborate closely with the external data management vendor to ensure timely, high-quality clinical trial data delivery and database integrity.
Provide statistical oversight and partnership to contract data management teams for CRF design, edit checks, data review, query management, and database lock activities.
Work cross-functionally with Clinical Operations, Data Management, Statistical Programming, and external vendors to support efficient and compliant clinical data workflows.
Participate in data review meetings with CROs and vendors to ensure consistency, quality, and readiness of clinical datasets for analysis and reporting.
Select, manage, and evaluate consulting biostatisticians and statistical programming vendors engaged across Cartesian's pipeline.
Serve as the primary interface with CRO statisticians: review statistical deliverables, provide clear direction on analytical methodology, and ensure CRO outputs meet Cartesian's standards.
Contribute to regulatory submissions and briefing documents requiring statistical input, including Type B/C meeting packages, SPA requests, IND amendments, and BLA preparation.
Participate in FDA statistical discussions; prepare and defend analytical approaches in regulatory interactions.
Collaborate with Clinical Operations, Regulatory Affairs, Medical Affairs, and CMC to ensure integrated, coherent data strategies across programs.