Associate Director, Biostatistics
About The Position
Capricor Therapeutics is a biotechnology company developing cell- and exosome-based therapies for rare diseases. The Associate Director, Biostatistics will join a lean team responsible for the company’s analyses and presented data, supporting the Deramiocel program in Duchenne muscular dystrophy-associated cardiomyopathy. Reporting to the Head of Biostatistics, this hands-on individual contributor will author Statistical Analysis Plans and provide the analyses that inform clinical and corporate decisions. The biostatistics team plans and executes trial analyses and communicates with regulatory agencies, the patient community, and the investment community. The role calls for deep SAP-authoring experience, sound statistical judgment, and the ability to communicate results clearly to technical and non-technical audiences. The position may also be eligible for a discretionary annual performance bonus and, depending on role level, long-term equity incentive awards in accordance with company policy.
Requirements
- PhD in Biostatistics, Statistics, or a related quantitative field.
- At least 8 years of biostatistics experience in clinical development.
- 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, including 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 role with no direct reports.
Nice To Haves
- 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.
Responsibilities
- Lead statistical strategy, study-design input, sample-size justification, and analysis plans for assigned studies.
- Author and review Statistical Analysis Plans (SAPs), tables, listings, and figures (TLF) shells, and statistical sections of protocols and clinical study reports (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.
- Oversee CRO biostatistics and programming deliverables, including independent validation and quality review.
- 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.
Benefits
- Employer-sponsored medical, dental, and vision coverage.
- Company-paid basic life and AD&D insurance.
- 401(k) plan with company match.
- Paid time off and company holidays.
- Paid parental leave.
- Additional voluntary benefits and wellness programs may also be available.
- May be eligible for a discretionary annual performance bonus.
- May be eligible for long-term equity incentive awards, depending on role level and company policy.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
