Senior Biostatistics Lead for Strategy and Submissions

Avalo Therapeutics, Inc.; Pennsylvania; Sur place; USD 140 000 - 210 000; Plein temps

Résumé du poste

Avalo Therapeutics, Inc. is seeking a Senior Manager / Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs.

This role will serve as the lead biostatistician for one or more programs and will partner with Clinical Development, Medical Affairs, Data Management, Regulatory Affairs, and external partners to ensure high-quality statistical strategy and submissions.

Qualifications

• Ph.D. in Biostatistics or related quantitative discipline with pharma/clinical research experience; or M.S. with substantial experience.
• Strong knowledge of clinical trial methodology, study design, analysis, and regulatory requirements.
• Experience supporting regulatory submissions and health authority interactions.
• Experience leading cross-functional teams and influencing development strategies.
• Expertise in adaptive designs, longitudinal analyses, survival analyses, and integrated analyses.
• Experience overseeing CROs and external statistical vendors.

Responsabilités

• Lead biostatistics strategy for one or more clinical development programs and studies.
• Serve as statistical representative on cross-functional study teams and governance committees.
• Collaborate with Clinical Development and Medical teams on study design and endpoint selection.
• Provide input on SAPs, DMPs, and study reports; ensure regulatory compliance.
• Interpret results and communicate findings to technical and non-technical audiences.
• Oversee CROs and external vendors to ensure high-quality deliverables and timelines.
• Support regulatory interactions and submissions with statistical input.
• Contribute statistical expertise to publications and evidence generation activities.

Connaissances

Biostatistics leadership

Clinical development

Regulatory submissions

Cross-functional collaboration

Study design

SAS

R

ICH/FDA/EMA knowledge

CRO management

Statistical analysis

Formation

Ph.D. in Biostatistics

M.S. in Biostatistics

Outils

SAS

R

Description du poste

Avalo Therapeutics, Inc. is seeking a Senior Manager / Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs.

This role will serve as the lead biostatistician for one or more programs and will partner with Clinical Development, Medical Affairs, Data Management, Regulatory Affairs, and external partners to ensure high-quality statistical strategy and submissions.