Jobs in Bothell, WA

About the role

The Associate Director / Director, Biostatistics provides statistical support to clinical studies, including the design, analyses, and interpretation of clinical trials. This position collaborates closely with cross-functional teams and provides scientifically rigorous statistical expertise on projects and protocols in support of clinical development and for publication and presentation.

What you'll bring

• PhD or Master ’s in Biostatistics, Statistics, or a related field.
• A minimum of 6 years (with a PhD) or 8 years (with a Master's) of biostatistics experience supporting clinical trials in the pharmaceutical, biotech, or CRO industry, or equivalent.
• Prior oncology clinical trial experience, including familia rity with standard response criteria (e.g., RECIST 1.1), oncology endpoints (e.g., overall survival, progression-free survival, objective response rate), and associated statistical methodology (e.g., survival/time-to-event analysis, group sequential and adaptive designs ).
• Proficiency in statistical programming languages (e.g., SAS, R)
• Knowledge of CDISC data standards (SDTM and ADaM ).
• K nowledge of drug submission requirements and relevant ICH and FDA/EMA guidelines, including the ICH E9(R1) estimand framework.
• Strong verbal and written communication skills, including the ability to convey complex statistical concepts to cross-functional, non-statistical audiences.
• Strong problem-solving skills and the ability to work both independently and collaboratively in a fast-paced environment.
• Strong attention to detail and a proven ability to manage multiple competing priorities.
• A minimum of 2 years of leadership or people-management experience is preferred.
• Experience supporting regulatory submissions (e.g., NDA, BLA) is a strong plus.
• Experience managing CROs and external statistical vendors, including oversight of outsourced statistical deliverables, is a plus.