AD Biostatistics - MASH

Associate Director, Biostatistics - MASH

Location: Hybrid in Pennsylvania / Massachusetts
Reports to: Vice President, Biostatistics & Data Science

Position Summary

The Associate Director, Biostatistics is a senior individual contributor who will independently lead biostatistical activities for assigned studies or projects at a clinical‑stage biopharmaceutical company, spanning all phases of clinical development through post‑marketing efforts. This role serves as the statistical lead and primary point of contact for study and project teams, translating organizational and program objectives into high‑quality statistical deliverables.

The Associate Director will drive statistical strategy execution, ensure scientific rigor and analytical excellence, and collaborate closely with internal and external partners to support evidence generation and regulatory objectives.

Key Responsibilities

• Independently lead biostatistical strategy, modeling, and analyses for assigned clinical studies or projects, in alignment with R&D and program objectives.
• Serve as the statistical point of contact for cross‑functional study teams, partnering closely with Clinical Development, Clinical Operations, Data Management, Medical Affairs, and external CROs.
• Perform and/or review complex statistical analyses and outputs, ensuring accuracy, quality, and regulatory readiness.
• Contribute to clinical protocol development, including statistical sections, and author or review Statistical Analysis Plans (SAPs) as needed.
• Lead analysis of clinical trial data and real‑world data to support evidence generation initiatives, including randomized controlled trials and observational studies.
• Provide statistical oversight and guidance to programmers and external partners, ensuring alignment with internal analytical standards and timelines.
• Apply working knowledge of CDISC standards (SDTM/ADaM) and data management workflows to support efficient, compliant analyses.
• Communicate complex statistical concepts and results clearly to both technical and non‑technical stakeholders.
• Contribute to scientific excellence through statistical innovation, internal knowledge sharing, and participation in external scientific conferences and forums.

Qualifications

• Ph.D. in Biostatistics or Statistics with 3-5 years of industry experience
• Demonstrated experience in the design, analysis, and interpretation of clinical trials and healthcare datasets.
• Strong foundation in advanced statistical methods and computing, with hands‑on experience using SAS and R.
• Working knowledge of pharmaceutical data standards and structures, including CDISC/SDTM/ADaM.
• Solid understanding of regulatory guidelines governing pharmaceutical development and clinical research.
• Proven ability to effectively communicate complex statistical analyses and insights to cross‑functional and non‑statistical audiences.
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities in a fast‑paced environment.

Why This Opportunity

This role offers the opportunity to operate with high visibility and autonomy, directly influencing clinical and regulatory decision‑making within a collaborative, science‑driven organization.

Salary: $180,000-220,000 base salary + bonus + stock + benefits