Associate Director Biostatistics

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

up to $250,000 + Bonus + Long-Term Incentives

Rare Disease | Clinical Development | Regulatory Strategy

About

Join a global biopharmaceutical organization with an industry-leading rare disease portfolio and a strong pipeline of innovative therapies.

We're seeking an Associate Director, Biostatistics to provide statistical leadership across clinical development programs and play a key role in study design, regulatory strategy, and cross-functional decision-making.

This is a highly visible role where Biostatistics is viewed as a strategic partner rather than simply a supporting function.

Why This Opportunity?

You'll work closely with Clinical Development, Regulatory Affairs, Programming, Data Management, and senior leadership to help shape development strategies and drive critical decisions across multiple programs.

This is an excellent opportunity for someone who enjoys combining technical expertise with broader development and regulatory influence.

What You'll Do

• 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, data interpretation, and decision‑making activities
• Collaborate with cross‑functional stakeholders across Biometrics, Clinical, Regulatory, and Safety

Requirements

• MS or PhD in Statistics, Biostatistics, Mathematics, or related quantitative field
• Experience serving as a lead statistician within clinical development
• Strong protocol, SAP, and CSR experience
• Experience supporting NDA, BLA, MAA, or similar regulatory submissions preferred
• FDA and/or EMA interaction experience is a plus
• Strong CRO oversight and stakeholder management skills
• Proficiency in SAS and/or R
• Experience with adaptive trial designs, Bayesian methods, or innovative statistical approaches is highly desirable
• Rare disease experience is preferred but not required

Why It's Attractive

Strategic role with significant visibility and influence

Strong focus on rare disease innovation

Exposure to study design, regulatory strategy, and development planning

Opportunity to partner directly with senior scientific and business leaders

Collaborative, science-driven culture

Boston-based organization with long-term stability and pipeline growth