Associate Director, Biostatistics

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. $185,000 - $225,000 a year Compensation and Benefits The posted salary range represents Capricor's good-faith estimate of the salary range reasonably expected to be paid for this position at the time of hire. Final compensation will be determined based on job-related factors, including the candidate's relevant experience, education, skills, certifications, scope of role, location, and internal equity. This position may also be eligible for a discretionary annual performance bonus and, depending on the level of the role, long-term equity incentive awards in accordance with company policy. Capricor Therapeutics offers a comprehensive benefits package that includes employer-sponsored medical, dental, and vision coverage; company-paid basic life and AD&D insurance; a 401(k) plan with company match; paid time off and company holidays; and paid parental leave. Additional voluntary benefits and wellness programs may also be available.