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Avalo Therapeutics · 21 hours ago

VP, Head of Biometrics

Wayne, PA

Full-time

Hybrid

Director/Executive

10+ years exp

Avalo Therapeutics is a clinical stage biotechnology company focused on developing treatments for immune-mediated inflammatory diseases. The Head of Biometrics will oversee biostatistics, data management, and statistical programming, ensuring high-quality data strategies and analyses that support clinical development decisions and regulatory submissions.

BiotechnologyTherapeutics

Responsibilities

Partner closely with internal study team and external CROs to ensure high-quality and timely deliverables for biostatistics, data management and programming

Contribute to regulatory submissions (INDs, NDAs, BLAs, global briefing documents) and participate in regulatory interactions with Health Authorities as required

Interfaces with CRO ensuring data and statistical reporting is secure and timely

Interprets study results and provide review of statistical summary reports of study results for accuracy and interpretation of data

Collaborates on implementation and analysis of all statistical aspects of research protocols

Provides statistical input into study design, sample size estimation, randomization schedules, and endpoint selection for clinical programs

Develops statistical analysis plans, including detailed textual description of planned analysis and mock-ups of data displays

Assists in development of CRFs, programming specifications, and additional study documents related to data flow and analyses

Performs statistical analyses, including hypothesis testing and modeling

Provides tabular and written summaries of analyses and statistical methodology

Reviews and provides comments on statistical summaries

Provides input to project timelines and ensures that project timelines for biostatistics deliverables are met

Ensures that project tasks are completed with acceptable quality

Attends team meetings and represents departmental needs for assigned projects

Ensures compliance with ICH, CDISC, and regulatory standards

May assist in developing policies and procedures (SOPs)

Additional tasks and projects as assigned

Qualification

BiostatisticsStatistical programmingClinical trial designRegulatory submissionsSASLeadershipCollaborationCommunication skillsPresentation skillsAttention to detailOrganization skills

Required

PhD or M.S. in Biostatistics, Statistics, or related quantitative field

Minimum 10 years of biostatistics/biometrics experience in clinical development, with strong preference for monoclonal antibody and/or immunology drug development experience

Proven leadership in late-stage trials and cross-functional team collaboration

Strong statistical programming in SAS

Excellent communication and collaboration skills with a team-oriented approach

Excellent presentation and writing skills

Ability to thrive in a small company environment: fast-paced, hands-on, collaborative, and adaptable

Self-motivated with a commitment to high quality, on-time deliverables

Demonstrated ability to identify and resolve issues and effectively manage timelines

Strong knowledge of clinical trial design, statistical methods, and regulatory requirements

Ability to synthesize results in graphic, oral, and written reports

Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies

Demonstrated attention to detail and outstanding organization skills