Senior Biostatistics Lead – Clinical Development (Remote)

Sumitomo Pharma; Atlanta (GA); Remote; USD 166,000 - 207,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Sumitomo Pharma America is seeking an Associate Director of Biostatistics to serve as the statistical lead for clinical development programs, providing strategic input on design, analysis, and regulatory submissions. You will partner with cross‑functional teams to ensure rigorous statistics and feasible plans, while guiding regulatory interactions and external collaborations.

You will lead statistical sections, interpret results, mentor statisticians, and apply innovative methods as appropriate

Qualifications

• Broad knowledge of statistical principles and clinical-trial methodology.
• Strong understanding of regulatory guidance (ICH, FDA, EMA, PMDA).
• Knowledge of CDISC standards.
• Experience with Bayesian methods or adaptive trial designs preferred.
• Proficiency in SAS and R.
• Ability to communicate complex statistics to technical and non-technical audiences.
• Proven ability to provide strategic leadership and cross-functional influence.

Responsibilities

• Lead statistical input for one or more clinical development programs, including study design and analysis strategies.
• Represent Biostatistics on cross-functional program and study teams.
• Lead statistical interactions with regulatory authorities and prepare briefing documents.
• Author or oversee statistical sections of protocols, SAPs, regulatory submissions, and publications.
• Provide statistical interpretation of results and support data-driven program decisions.
• Identify risks and mitigation strategies across projects.
• Oversee CRO and external vendor statistical activities and timelines.
• Provide mentorship to statisticians and statistical programmers.
• Evaluate innovative methods, including Bayesian and adaptive designs.
• Contribute to governance, standards, and capability development.

Job description

Sumitomo Pharma America is seeking an Associate Director of Biostatistics to serve as the statistical lead for clinical development programs, providing strategic input on design, analysis, and regulatory submissions. You will partner with cross‑functional teams to ensure rigorous statistics and feasible plans, while guiding regulatory interactions and external collaborations.

You will lead statistical sections, interpret results, mentor statisticians, and apply innovative methods as appropriate