Director, Biostatistics

Scorpion Therapeutics; United States; On-site; USD 120,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in the United States is seeking a senior Biostatistician to provide strategic statistical input across clinical development plans and trial designs. You will lead statistical activities for studies and serve as the biostatistics representative on cross-functional teams.

The role emphasizes collaboration on SAPs, protocol development, and DMC coordination, mentoring junior staff, and aligning analyses with ICH and regulatory standards while exploring AI/ML-enabled approaches.

Qualifications

• Ph.D. or M.S. in Statistics/Biostatistics; minimum 8 years (Ph.D.) or 12 years (M.S.) biotech/pharma statistical experience.
• Hands-on experience designing/analyzing clinical trials and applying machine learning.
• Solid knowledge of ICH and other biostatistical regulatory requirements.
• Strong verbal/written communication and collaboration; ability to work independently; ability to identify business-relevant questions, lead projects, and mentor.
• Proficiency in R.

Responsibilities

• Provide statistical support and input to clinical development plans and target product profiles, proof of concept criteria, and Phase 1-4 trial designs.
• Represent Biostatistics on cross-functional program teams; serve as lead statistician for studies.
• Collaborate on study design, protocol development, statistical analysis plan (SAP) and analysis specifications.
• Support protocol development and SAP/specifications via direct involvement and guidance to junior staff.
• Plan and prepare DMC materials; coordinate DMC reviews with an independent statistical data analysis center.
• Partner with data management and clinical operations on database development, data collection, and cleaning.
• Work with statistical programming to ensure correct dataset/output programs and that analyses follow protocols/SAPs.
• Provide statistical input for global health authority documents and responses.
• Support primary/secondary publications and assist with accurate data interpretation.
• Address methodological challenges in exploratory clinical research; integrate multimodal data (e.g., biomarkers, imaging, real-world data).
• Drive department initiatives, best practices, and guidelines; stay current on statistical/drug development/regulatory guidance.
• Propose and evaluate novel approaches aligned with AI/ML efforts.

Skills

Clinical trial design

Biostatistics

Machine learning

Communication

Mentoring

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Tools

R programming

Job description

Responsibilities:

• Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and Phase 1-4 trial designs.
• Represent Biostatistics on cross-functional program teams; serve as lead statistician for studies.
• Collaborate on study design, protocol development, statistical analysis plan (SAP) and analysis specifications.
• Support protocol development and SAP/specifications via direct involvement and guidance to junior staff.
• Plan and prepare DMC materials; coordinate DMC reviews with an independent statistical data analysis center.
• Partner with data management and clinical operations on database development, data collection, and cleaning.
• Work with statistical programming to ensure correct dataset/output programs and that analyses follow protocols/SAPs.
• Provide statistical input for global health authority documents and responses.
• Support primary/secondary publications and assist with accurate data interpretation.
• Address methodological challenges in exploratory clinical research; integrate multimodal data (e.g., biomarkers, imaging, real-world data).
• Drive department initiatives, best practices, and guidelines; stay current on statistical/drug development/regulatory guidance.
• Propose and evaluate novel approaches aligned with AI/ML efforts.

Qualifications/Skills:

• Ph.D. or M.S. in Statistics/Biostatistics; minimum 8 years (Ph.D.) or 12 years (M.S.) biotech/pharma statistical experience.
• Hands-on experience designing/analyzing clinical trials and applying machine learning.
• Solid knowledge of ICH and other biostatistical regulatory requirements.
• Strong verbal/written communication and collaboration; ability to work independently; ability to identify business-relevant questions, lead projects, and mentor.
• Proficiency in R.

Preferred Qualifications:

• Leading disease-area statistical strategy; enterprise initiative experience across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams.
• Familiarity with AI/ML and diverse data sources.
• Contributions to external working groups or published statistical innovation.