Senior Biostatistician

About the Role

As a Senior Biostatistician on our Oncology Development team, you will play a critical role in advancing innovative treatments for patients worldwide. We are seeking an experienced biostatistician to lead statistical activities for medium complexity studies, contributing to study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation, and clinical study report input and review.

Key Responsibilities

• Protocol Development and Statistical Analysis: Develop and execute statistical analysis plans, contribute to study design, and review Case Report Forms (CRFs). Ensure high-quality data through collaboration with the data manager and internal statistical programmers.
• Drug Development Strategy: Provide input on multiple aspects of the development plan, ensuring scientifically sound study designs that meet regulatory requirements and deliver pre-specified product profiles.
• CRO / Vendor Oversight: Review proposals, establish procedures, and ensure deliverables from CROs/vendors are accurate and timely.
• Global Health Authority Interaction / Negotiation: Contribute to documents submitted to global health authorities and may participate in meetings or teleconferences.
• Improving Drug Development Efficiency: Participate in moderately complex biostatistical initiatives to improve harmonization and efficiency, leading to cost savings and shortened timelines.

Requirements

We are looking for candidates with a PhD in statistics or biostatistics, preferably with 4+ years of experience in the pharmaceutical industry. A Master's Degree is also acceptable with relevant experience. The successful candidate will have strong leadership skills, excellent communication abilities, and be able to work independently with minimal supervision.

What We Offer

Daiichi Sankyo offers a competitive salary range of $120,000-$160,000 per year, depending on experience. Our comprehensive benefits package includes medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for professional growth and development.