Pharvaris – a clinical-stage company focused on bringing an oral bradykinin B2 receptor antagonist to patients – is seeking a highly motivated Associate Director of Statistical Programming to join and build impeccable statistical programming capabilities for producing analysis datasets and reports following international standards defined by health authorities
This position is within a highly collaborative and international department that strives to achieve high quality and excellent results. This role may be based in the Boston area (MA USA), Zug (Switzerland) or in Leiden, the heart of biotech in The Netherlands and reports to the Head of Statistical Programming, who is based in the USA. We offer talented staff a great working environment, dedicated and driven co-workers, short lines of communications and an attractive compensation and benefits package.
Responsibilities
- Serve as the lead statistical programmer on multiple clinical studies, accountable for the programming related deliverables in good quality and compliance.
- Manage and provide oversight for statistical programming FSPs, contractors, and CROs in support of clinical trials and biopharmaceutical research
- Represent statistical programming function at internal cross-functional teams and collaborations with external parties
- Provide technical leadership and close governance on statistical programming activities to ensure the individual and integrated studies compliant with regulatory requirement; ensure high quality and efficiency in analysis outputs (analysis datasets, tables, figures, and listings) and documentations
- Demonstrate regulatory submission experience and provide insights into building SDTM and ADaM datasets.
- Provide nimble support for ad-hoc and exploratory analyses to address queries from management and KOLs and aid internal decisions in clinical development planning
- Provide input in building capabilities for quality-controlled analyses supporting regulatory queries, publications, and other ad-hoc business deliverables
- Contribute to the development and implementation of technologies that impact analysis and reporting, support to develop statistical programming infrastructure and processes.
- Reinforce the collaboration with internal and external stakeholders to ensure effective partnerships across development teams
- Ensure all programming activities adhere to department, company, and industry standards.
Qualifications
- Degree (BSc) in a scientific, preferably biomedical discipline
- Minimum 10 years of experience in statistical programming in a pharmaceutical/biotech or CRO setting; preferably with 3 or more years of experience in managing statistical programming FTEs, FSPs/contractors, or CRO from the sponsor side
- Thorough insight into drug development from development, registration, launch through life cycle management; good knowledge of ICH GCP standards
- Good understanding of outsourced programming model, strong vendor management experience
- Strong knowledge of regulatory requirement including eCTD submission standards, CDISIC structure and elements
- Excellent hands-on skills and technical expertise in SAS and standard statistical computing systems, proficient in database management programming, server environment, up to date statistical programming software and technologies
- Strong leadership, interpersonal, and organizational skills; track record of representing statistical programming in cross-functional collaborations
- Good team player with result-oriented attitude and can-do mentality
- Clear and intelligent communicator, both verbally in project teams and written in reporting; fluent in scientific and business English