Associate Director - Biostatistics

Salary Range: 185000 to 225000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

Lead statistical strategy, study design input, sample-size justification, and analysis plans for assigned studies.
Author and review Statistical Analysis Plans (SAPs), TLF shells, and statistical sections of protocols and CSRs.
Oversee analysis execution, interpretation, and presentation of study results for clinical and corporate decision-making.
Provide statistical input to regulatory submissions and health authority interactions.
Ensure analyses align with ICH E9 and applicable regulatory expectations.
Partner with Statistical Programming, Data Management, Clinical Science, and Medical Affairs.
Provide oversight of CRO biostatistics and programming deliverables, including independent validation and quality review of their work.
Represent biostatistics in cross-functional, regulatory, investor, and patient-community discussions.
Support Data Safety Monitoring Boards (DSMBs) and interim analyses as needed.
Deliver ad hoc analyses supporting publications, medical congress presentations, and investor communications.
Contribute to the development and maintenance of biostatistics SOPs and best practices.

Required Qualifications

PhD in Biostatistics, Statistics, or a related quantitative field required.
8+ years of biostatistics experience in clinical development; level (Associate Director or Director) commensurate with experience.
Demonstrated experience authoring SAPs, with strong expertise in clinical trial design, ICH E9, and statistical methodology.
Experience supporting regulatory submissions and interactions.
Excellent written and verbal communication skills, with the ability to explain complex statistical concepts to diverse audiences.
Proficiency with SAS and/or R, including building programming tools to support analysis and validation.
Individual contributor; no direct reports.

Preferred Qualifications

Experience supporting products in both pre-approval and post-approval stages.
Rare disease, cell therapy, or other advanced-therapy experience.
Familiarity with CDISC standards (SDTM/ADaM) and FDA submission data requirements.

Why Capricor?

Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.

Come Work With Us

At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.

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