Remote Biostatistics Lead — Clinical Development

Sumitomo Pharma; Bismarck (ND); Remote; USD 166.000 - 207.000; Vollzeit

Zusammenfassung

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across one or more clinical development programs, including study design, analysis plans, regulatory submissions, and external collaborations. You will lead statistical input, guide decisions, and ensure rigorous methodologies in Oncology and related areas.

The role demands strong SAS and R expertise, experience with CDISC standards, and engagement with CROs.

Qualifikationen

• PhD in Statistics or Biostatistics with 5+ years in pharma/biotech.
• MS with 8+ years in pharmaceutical/biotech industry accepted.
• Experience leading clinical development programs and trials.
• Experience supporting regulatory interactions and submissions is preferred.
• Oncology or hematology development experience preferred.
• Experience overseeing CROs/vendors required.

Aufgaben

• Lead statistical input for one or more clinical programs: design, analyses, and decision criteria.
• Represent Biostatistics on cross-functional teams and guide key decisions.
• Lead regulatory interactions and prepare briefing documents and responses.
• Author/review statistical sections of protocols, SAPs, submissions, and publications.
• Provide interpretation of study results and data-driven program recommendations.
• Identify risks and mitigate regulatory/operational issues.
• Oversee CRO/vendor activities and ensure quality and timelines.
• Mentor statisticians and statistical programmers; provide technical leadership.
• Apply Bayesian, adaptive, or complex designs where appropriate.
• Contribute to governance, standards, and capability development.

Kenntnisse

Statistical leadership

Cross-functional collaboration

Regulatory interactions

Bayesian methods

Adaptive/ complex trial design

SAS

R

Ausbildung

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

SAS

R

CDISC

Jobbeschreibung

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across one or more clinical development programs, including study design, analysis plans, regulatory submissions, and external collaborations. You will lead statistical input, guide decisions, and ensure rigorous methodologies in Oncology and related areas.

The role demands strong SAS and R expertise, experience with CDISC standards, and engagement with CROs.