Associate Director, Biostatistics

Sumitomo Pharma America, Inc.

Lead biostatistics efforts for oncology clinical projects at Sumitomo Pharma. Manage statistical documentation and mentor junior biostatisticians while collaborating with cross-functional teams.

Posted 6/9/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $165,800 - $207,200 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

biostatisticsstudy designstatistical analysisBayesian modelingSAS programmingR programmingSDTM datasetsADaM datasetsTLFs specificationsstatistical reporting

Soft Skills

leadershipcoachingcommunicationwritingproject managementteam collaborationproblem-solvingprofessional developmentquality assurancemultitasking

Certifications

PhD in statisticsMS in biostatistics