Associate Director, Biostatistics
Capricor Therapeutics
Summary
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.
Job description
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.
Requirements
- PhD in Biostatistics, Statistics, or a related quantitative field required.
- 8+ years of biostatistics experience in clinical development.
- Demonstrated experience authoring SAPs.
- Strong expertise in clinical trial design, ICH E9, and statistical methodology.
- Experience supporting regulatory submissions and interactions.
- Excellent written and verbal communication skills.
- Proficiency with SAS and/or R, including building programming tools to support analysis and validation.
- Individual contributor; no direct reports.
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- 401(k) Matching
- Paid Time Off
- Company Holidays
- Paid Parental Leave
- Wellness Programs
- Annual Performance Bonus
- Equity Incentive Awards
Company overview
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company headquartered in San Diego, California, dedicated to developing transformative cell and exosome-based therapeutics for serious diseases. Founded in 2005, the company focuses primarily on rare diseases with high unmet medical needs. Capricor's lead product candidate is Deramiocel, an allogeneic cardiac-derived cell therapy currently in late-stage clinical development for the treatment of Duchenne muscular dystrophy (DMD), the most severe form of muscular dystrophy. The company's innovative approach leverages cardiosphere-derived cells that have demonstrated potent immunomodulatory and anti-fibrotic effects in preclinical and clinical studies. Additionally, Capricor is advancing its proprietary StealthX™ exosome technology platform, which enables targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics for various applications including vaccinology. As a publicly traded company, Capricor maintains strategic partnerships with leading academic institutions and has established commercialization agreements with pharmaceutical partners for its DMD therapy. The company employs 51-200 professionals and continues to advance its pipeline through rigorous clinical development programs aimed at addressing significant unmet medical needs in rare diseases.