Avalo Therapeutics
Sr. Manager/ Associate Director, Statistical Programming
Chesterbrook, PA · Director
Sponsorship not specifiedDetected 33 days ago
SQLGCPStatisticsProject ManagementStakeholder ManagementProcess ImprovementHRClinical TrialsFDA RegulatorySASLeadershipCommunicationCollaborationBiostatistics
About the role
- The Senior Manager / Associate Director, Statistical Programming will provide strategic and operational leadership for statistical programming activities across one or more clinical development programs.
- This individual will be responsible for the planning, execution, oversight, and delivery of statistical programming outputs supporting clinical trials, regulatory submissions, publications, and internal decision-making.
- This role offers the opportunity to influence programming standards, mentor team members, and contribute to the continued growth of Avalo's Biometrics organization.
Responsibilities
- Lead statistical programming activities for one or more clinical studies, programs, or therapeutic areas.
- Manage and oversee outsourced statistical programming activities conducted by CROs and external partners.
- Review and validate datasets, TLFs, specifications, and programming documentation generated by vendors.
- Establish and maintain effective partnerships with external programming and biometrics vendors.
- Collaborate on the development of data review tools, dashboards, visualizations, and other statistical applications to support clinical development activities.
Requirements
- Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline.
- Bachelor's degree with significant relevant experience will also be considered.
Nice to have
- Advanced proficiency in SAS programming, including Base SAS, Stat, Graph, Macro, SQL, and generation of submission-ready deliverables.
- Working knowledge of R or other modern statistical programming languages is a plus.
- Experience with producing publication-quality statistical graphics using SAS/R is a plus
- Experience with building/contributing to global SAS macro library for TFL generation is highly desirable
- Extensive experience with CDISC standards, including SDTM, ADaM, Define.xml, controlled terminology, and regulatory submission requirements.
- Experience with Pinnacle 21 is a plus
- Strong understanding of ICH guidelines, GCP, FDA, EMA, and other global regulatory requirements.
- Experience managing external CROs, FSPs, or programming vendors.
Skills
- Assist with establishing framework of programming environment, including library of macros.
Benefits
- Support regulatory submissions, health authority interactions, publications, and ad hoc analyses.
- Partner closely with Biostatistics, Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other stakeholders to deliver high-quality clinical data and analyses.
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