Senior Biostatistics Lead - Rare Disease Development

i‑Pharm Consulting; Boston (MA); On-site; USD 225,000 - 275,000; Full time

Job summary

i‑Pharm Consulting in Boston seeks an Associate Director, Biostatistics to provide statistical leadership across clinical development programs and to shape study design, regulatory strategy, and cross-functional decision-making.

This highly visible role partners with Clinical Development, Regulatory Affairs, Programming, Data Management, and senior leadership to drive development plans and critical decisions across multiple programs, with emphasis on rare disease and strategic statistics.

Qualifications

• Lead statistician within clinical development.
• Strong protocol, SAP, and CSR experience.
• Experience supporting NDA, BLA, MAA submissions.
• FDA and/or EMA interaction experience is a plus.
• CRO oversight and stakeholder management skills.
• Proficiency in SAS and/or R.
• Experience with adaptive trial designs and Bayesian methods.

Responsibilities

• Lead statistical strategy across clinical studies and development programs.
• Provide input into study design, endpoint selection, and sample size determination.
• Author and review protocols, SAPs, CSRs, and other key study documents.
• Support regulatory submissions and health authority interactions.
• Manage CRO and vendor statistical deliverables.
• Contribute to development plans and data interpretation.
• Collaborate with Biometrics, Clinical, Regulatory, and Safety teams.

Skills

Biostatistics leadership

Statistical analysis plan (SAP) input

SAS and R

Regulatory submissions

CRO/vendor oversight

Adaptive trial designs

Bayesian methods

Rare disease experience

Education

MS or PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

i‑Pharm Consulting in Boston seeks an Associate Director, Biostatistics to provide statistical leadership across clinical development programs and to shape study design, regulatory strategy, and cross-functional decision-making.

This highly visible role partners with Clinical Development, Regulatory Affairs, Programming, Data Management, and senior leadership to drive development plans and critical decisions across multiple programs, with emphasis on rare disease and strategic statistics.