Associate Director, Biostatistics

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Sumitomo Pharma America, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.

📋 Description

• Serve as the biostatistics lead for one or more studies within a project team, offering expertise in study design, operations, decision rules, and analysis planning. • Author and oversee the production of statistical sections of protocols and analysis plans, and contribute to the statistical sections of publications across multiple clinical projects. • Provide coaching and management for junior biostatisticians, fostering their professional development and ensuring high-quality output. • Plan, manage, and supervise the statistical activities conducted by Contract Research Organizations (CROs) to ensure alignment with project objectives and standards. • Offer guidance to junior statisticians and statistical programmers on developing SDTM/ADaM datasets and TLFs (Tables, Listings, and Figures) specifications, as well as perform quality checks on statistical programming efforts as needed.

🎯 Requirements

• PhD or MS in statistics or biostatistics. PhD is preferred. • Minimum 5-year (for PhD) or 8-year (for MS) experience in clinical trials is required • Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications into clinical trial • Strong statistical leadership in a multi-functional project environment: able to manage many projects simultaneously as well as conflicting priorities • Effective writing and communication skills: able to author various statistical documents; able to explain to team clearly and help team understand complex statistical design, methodology, decision rule, analysis plan and statistical report • Experience with Bayesian modeling and Analysis • Experienced with SAS programming, R programming and other statistical software • Experience with AI or agentic AI in statistical reporting is a plus • People management is a plus

🏖️ Benefits

• merit-based salary increases • short incentive plan participation • eligibility for our 401(k) plan • medical, dental, vision, life and disability insurances • flexible paid time off • 11 paid holidays plus additional time off for a shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter