Director, Biostatistics – Oncology Leadership (Equity)

Hartmann Young; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Hartmann Young, a clinical-stage oncology biotechnology partner, is seeking a Director of Biostatistics to provide statistical leadership across its development portfolio. The role involves hands-on leadership from early-phase through registrational development, partnering with Clinical Development, Regulatory Affairs, and Data Management.

The successful candidate will oversee study designs, robust statistical analyses, and regulatory interactions with authorities such as FDA/EMA, while

Qualifications

• PhD or Master's in Biostatistics or related quantitative discipline.
• Typically 8-12+ years of clinical biostatistics experience in biotech/pharma; Master’s may require more.
• Experience leading oncology clinical development and regulatory interactions.

Responsibilities

• Lead biostatistics for oncology programs from protocol development to regulatory submission.
• Design Phase I-III trials with endpoints, sample size, interim analyses, and adaptations.
• Prepare and review SAPs, DHPs, and CSRs; ensure CDISC compliant deliverables.
• Manage CROs/vendors, timelines, budgets and quality of deliverables.
• Mentor junior biostatisticians and coordinate with cross-functional teams.

Skills

SAS

R

Leadership

Communication

CRO management

Education

PhD or Master’s in Biostatistics

8-12+ years in biotech/pharma

Tools

CDISC (SDTM/ADaM)

Clinical trial design

Job description

Hartmann Young, a clinical-stage oncology biotechnology partner, is seeking a Director of Biostatistics to provide statistical leadership across its development portfolio. The role involves hands-on leadership from early-phase through registrational development, partnering with Clinical Development, Regulatory Affairs, and Data Management.

The successful candidate will oversee study designs, robust statistical analyses, and regulatory interactions with authorities such as FDA/EMA, while