Remote Biostatistics Lead - Clinical Development

Sumitomo Pharma; Annapolis (MD); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. is seeking an Associate Director of Biostatistics to provide strategic statistical leadership across clinical development programs.

You will design studies, oversee regulatory submissions, and collaborate with cross-functional teams to ensure rigorous statistical approaches. The role emphasizes interaction with regulators, mentorship of statisticians, and adoption of innovative methods such as Bayesian approaches in oncology/hematology development.

Qualifications

• PhD in Statistics, Biostatistics, or a related quantitative discipline with at least 5 years of relevant experience in the pharmaceutical/biotech industry, or an MS with at least 8 years of relevant experience.
• Significant experience providing statistical leadership for clinical development programs and trials.
• Experience supporting regulatory interactions and marketing applications is strongly preferred.
• Oncology or hematology clinical development experience is preferred.
• Experience overseeing CROs, vendors, or external statistical partners is required.

Responsibilities

• Serve as the biostatistics lead for one or more clinical development programs, providing strategic statistical input into development plans, study designs, decisions, and analysis strategies.
• Represent Biostatistics on cross-functional teams and ensure statistical considerations are incorporated into key development decisions.
• Lead statistical interactions with regulatory authorities, including briefing documents and responses to regulatory questions.
• Author or oversee statistical sections of protocols, SAPs, regulatory submissions, publications, and other scientific documents.
• Provide statistical interpretation of study results and support data-driven program decisions.
• Identify statistical, operational, and regulatory risks and recommend mitigation strategies.
• Oversee CRO and external vendor statistical activities, including scope definition, quality review, timelines, and delivery of outputs.
• Provide technical leadership, coaching, and mentorship to statisticians and statistical programmers.
• Evaluate and apply innovative statistical methods, including Bayesian approaches and adaptive/complex trial designs.
• Contribute to departmental standards, governance, and capability development.

Skills

Statistical leadership

Clinical trial design

Regulatory submissions

Bayesian methods

SAS

R

Cross-functional collaboration

Education

PhD in Statistics or Biostatistics

MS in related field

Tools

SAS

R

Job description

Sumitomo Pharma Co., Ltd. is seeking an Associate Director of Biostatistics to provide strategic statistical leadership across clinical development programs.

You will design studies, oversee regulatory submissions, and collaborate with cross-functional teams to ensure rigorous statistical approaches. The role emphasizes interaction with regulators, mentorship of statisticians, and adoption of innovative methods such as Bayesian approaches in oncology/hematology development.