Avalo Therapeutics
Sr. Manager/ Associate Director, Biostatistics
Chesterbrook, PA · Director
Sponsorship not specifiedDetected 33 days ago
StatisticsProcess ImprovementHRClinical TrialsClinical ResearchFDA RegulatorySASResearchExperimental DesignLeadershipCommunicationPublic SpeakingBiostatisticsRegulatory Affairs
About the role
- Senior Manager / Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs.
- This role offers the opportunity to influence development strategy, advance innovative statistical methodologies, and contribute to regulatory and business decision-making across the organization.
- Statistical Leadership & Clinical Development
Responsibilities
- Lead the biostatistics strategy for one or more clinical development programs and studies.
- Provide strategic input into clinical development plans, including study design, endpoint selection, sample size determination, interim analyses, and decision criteria.
- Identify potential statistical, operational, or scientific challenges and proactively develop solutions.
- Evaluate and implement innovative statistical methodologies to enhance development strategies and study efficiency.
- Develop and/or oversee analysis strategies, including tables, listings, and figures (TLFs), ensuring methodological rigor and regulatory compliance.
- Contribute to regulatory strategies and support global submissions.
- Strong knowledge of clinical trial methodology, study design, statistical analysis, and regulatory requirements.
- Expertise in statistical methods applicable to clinical development, including adaptive designs, longitudinal analyses, survival analyses, and integrated analyses.
Requirements
- Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 4 years of pharmaceutical, biotechnology, or clinical research experience
- or M.S. with a minimum of 6 years of experience
- Proficiency in SAS and/or R.
- Strong understanding of ICH, FDA, EMA, and other global regulatory guidance.
- Experience with real-world evidence, observational studies, HEOR, or post-marketing research is a plus.
Benefits
- Experience supporting regulatory submissions and health authority interactions.
- Represent Biostatistics during interactions with health authorities, including FDA, EMA, PMDA, and other regulatory agencies, as appropriate.
- Collaborate with Clinical Development and Medical teams to design clinical studies aligned with program objectives, regulatory expectations, and business needs.
- Support quantitative decision-making, including benefit-risk assessments, probability of technical success analyses, and Go/No-Go evaluations.
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