Senior Manager, Biostatistics

Scorpion Therapeutics; San Carlos (CA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager, Biostatistics to provide statistical leadership for complex cell therapy oncology studies. You will design studies, analyze data, interpret results, and communicate findings to cross-functional teams.

Your role includes leading statistical activities, authoring SAPs and CSRs, and collaborating with CROs and programmers to deliver high-quality outputs in a remote-friendly environment.

Qualifications

• Ph.D. in Statistics/Biostatistics (3–5 years healthcare industry) or M.S. (6–8 years healthcare).
• Strong oncology clinical development experience (design and analysis of early- and late-phase trials).
• Solid theory and applied statistics knowledge (survival analysis, PROs, health economics).
• Strong decision-making with a cross-functional/global perspective; able to operate with limited/ambiguous information.
• Strong verbal, written, and presentation skills.
• Experience leading collaborative efforts to obtain/analyze complex data.
• Proficiency in SAS; R familiarity highly desirable.

Responsibilities

• Serve as lead statistician for one or more clinical studies and support program-level statistical strategy.
• Lead statistical activities for assigned studies; collaborate with statistical programmers and CRO partners to deliver timely, high-quality statistical outputs.
• Author and review statistical sections of study protocols, SAPs, CSRs, regulatory submissions, and publications.
• Maintain current knowledge of statistical methodologies, regulatory guidance, and oncology drug development best practices.
• Contribute statistical expertise to due diligence and cross-functional evaluations as needed.
• Create networks with external statistical/programming collaborators and influence internal decisions to ensure quality of study designs/analyses.
• Contribute to process improvements, standards development, and statistical best practices within Biostatistics.
• Work effectively in cross-functional teams to resolve study-level operational and scientific challenges.
• Contribute to knowledge sharing within the department.

Skills

SAS & programming

Survival analysis

PROs (Patient-Reported Outcomes)

Health economics

Cross-functional collaboration

Communication & presentation

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

SAS

R

Job description

Overview:

The Senior Manager, Biostatistics provides statistical leadership for complex clinical studies in cell therapy oncology programs. Responsible for study design, statistical analysis, interpretation of results, and communication of statistical findings.

Responsibilities:

• Serve as lead statistician for one or more clinical studies and may support program-level statistical strategy.
• Lead statistical activities for assigned studies; collaborate with statistical programmers and CRO partners to deliver timely, high-quality statistical outputs.
• Author and review statistical sections of study protocols, statistical analysis plans, clinical study reports, regulatory submission documents, and publications (abstracts/posters).
• Maintain current knowledge of statistical methodologies, regulatory guidance, and oncology drug development best practices.
• Contribute statistical expertise to due diligence and cross-functional evaluations as needed.
• Create networks with external statistical/programming collaborators and influence internal decisions to ensure quality of study designs/analyses and appropriate conclusions.
• Contribute to process improvements, standards development, and statistical best practices within Biostatistics.
• Work effectively in cross-functional teams to resolve study-level operational and scientific challenges.
• Contribute to knowledge sharing within the department.

Required Qualifications/Skills:

• Ph.D. in Statistics/Biostatistics (3–5 years relevant industry experience in healthcare) or M.S. (6–8 years relevant industry experience in healthcare).
• Strong experience in oncology clinical development (design and analysis of early- and late-phase trials).
• Sound theoretical/applied statistics knowledge (including survival analysis, patient-reported outcomes, health economics).
• Strong decision-making with cross-functional/global perspective; can operate with limited/ambiguous information.
• Strong verbal, written, and presentation skills.
• Experience leading collaborative efforts to obtain/analyze complex data.
• Proficiency in SAS; R familiarity highly desirable.

Preferred:

• Working knowledge of FDA/EMA/ICH statistical guidance; regulatory submission experience (NDA/BLA/MAA) preferred.

Work Environment:

Professional office or remote work environment; routine use of standard office equipment and technology.