Associate Director, Biostatistics

About the role

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

As the Associate Director, Biostatistics at Capricor, you will join a lean, high-impact team that owns all analysis and presented data across the company. Reporting to the Head of Biostatistics, you will be a hands-on biostatistician supporting the Deramiocel program in cardiomyopathy associated with Duchenne muscular dystrophy (DMD), authoring SAPs and delivering the analyses behind clinical and corporate decisions.

The team plans and executes every trial analysis and is forward-facing to regulatory agencies, the patient community, and the investment community. The ideal candidate brings deep SAP authoring experience, sound statistical judgment, and the ability to communicate results clearly to technical and non-technical audiences.

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.

Recruiting Fraud Notice

• Capricor does not use Skype for interviews or recruiting activities.
• Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com.
• Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.

Notice to Recruiting Agencies

Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. Agencies that contact hiring managers directly, solicit business, or submit candidates without prior approval will not be considered for engagement. Any unsolicited submissions will become the property of Capricor Therapeutics, and no fees will be paid for candidates hired as a result of such submissions. We appreciate your cooperation and respect for this policy.