Associate Director, Biostatistics - Rare-Disease Cell Therapy

Capricor Therapeutics; United States; On-site; USD 185,000 - 225,000; Full time

Job summary

Capricor Therapeutics is seeking an Associate Director, Biostatistics to join our lean, high‑impact team supporting the Deramiocel program for Duchenne. You will be hands‑on, author SAPs, shape study design, and deliver analyses that inform regulatory discussions and investor communications.

You will partner with cross‑functional groups, oversee CRO statistics, and ensure compliance with ICH E9 and CDISC standards where applicable.

Qualifications

• PhD in Biostatistics, Statistics, or a related quantitative field.
• 8+ years of biostatistics experience in clinical development.
• Experience authoring SAPs and with clinical trial design.
• Experience supporting regulatory submissions and interactions.
• Excellent written and verbal communication skills.
• Proficiency with SAS and/or R.
• Individual contributor; no direct reports.

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.

Skills

SAP authoring

Clinical trial design

ICH E9

Communication skills

Regulatory submissions

Education

PhD in Biostatistics or related field

Tools

SAS

R

Job description

Capricor Therapeutics is seeking an Associate Director, Biostatistics to join our lean, high‑impact team supporting the Deramiocel program for Duchenne. You will be hands‑on, author SAPs, shape study design, and deliver analyses that inform regulatory discussions and investor communications.

You will partner with cross‑functional groups, oversee CRO statistics, and ensure compliance with ICH E9 and CDISC standards where applicable.