Senior Biostatistics Lead, Remote — Clinical Programs

Sumitomo Pharma; Austin (TX); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America (SMPA) seeks an Associate Director, Biostatistics to lead statistical strategy across clinical programs, shaping design, analysis, and regulatory submissions. You will partner with cross-functional teams to ensure rigorous methods and clear decision criteria while guiding external partners and vendors.

You will provide technical leadership, foster regulatory interactions, and mentor statisticians in a fast-paced setting, with primarily remote work and periodic on-site

Qualifications

• PhD in Statistics or Biostatistics with relevant industry experience.
• Significant leadership in clinical development programs and trials.
• Experience supporting regulatory interactions and submissions is preferred.
• Oncology or hematology development experience is preferred.
• Experience overseeing CROs, vendors, or external statistical partners is required.

Responsibilities

• Serve as biostatistics lead for one or more clinical programs and advise on design and analysis strategies.
• Represent Biostatistics on cross-functional teams and contribute to key development decisions.
• Lead regulatory interactions, including briefing documents and responses.
• Author/review statistical sections of protocols, SAPs, submissions, and publications.
• Provide interpretation of results and quantify benefit-risk for program decisions.
• Identify risks and mitigation strategies; oversee CRO/statistical vendors.
• Provide technical leadership and mentorship to statisticians and programmers.

Skills

Statistical leadership

SAS

R

Regulatory guidance

Cross-functional leadership

Communication

Bayesian methods

Adaptive/complex trial designs

Education

PhD in Statistics/Biostatistics

5+ years in pharma/biotech

Experience with regulatory submissions

Tools

SAS

R

CDISC

Job description

Sumitomo Pharma America (SMPA) seeks an Associate Director, Biostatistics to lead statistical strategy across clinical programs, shaping design, analysis, and regulatory submissions. You will partner with cross-functional teams to ensure rigorous methods and clear decision criteria while guiding external partners and vendors.

You will provide technical leadership, foster regulatory interactions, and mentor statisticians in a fast-paced setting, with primarily remote work and periodic on-site