Responsibilities:
- Support statistical programming for late-stage drug/vaccine clinical development projects.
- Develop and execute statistical analysis/reporting deliverables (e.g., safety/efficacy datasets, tables, listings, figures) from individual trials through global regulatory submissions and post-marketing support.
- Design and maintain statistical datasets for multiple stakeholder groups (clinical development, outcomes research, safety evaluation).
- Collaborate with statistics and other stakeholders to ensure efficient project execution and timely, high-quality deliverables.
- Serve as the statistical programming point of contact and knowledge holder across the product lifecycle.
- Apply state-of-the-art scientific methods/tools across discovery, development, regulatory approval, manufacturing, and marketing.
- Lead one or more projects.
Requirements:
- Masterβs degree (or equivalent) in Computer Science/Statistics/Applied Mathematics/Life Sciences/Engineering or related field + 3 years SAS programming in a clinical trial environment; OR Bachelorβs + 5 years.
- Experience with CDISC and ADaM standards.
- Experience designing/developing complex programming algorithms with compliance and deliverable quality.
- SAS expertise for clinical trial programming: data steps, procedures, SAS/MACRO, SAS/GRAPH.
- Systems/database expertise; ability to understand analysis plans and statistical terminology/concepts.
- Ability to design statistical databases, anticipate stakeholder needs, and collaborate effectively.
- Familiarity with clinical data management concepts.
- Strong written/oral/presentation and interpersonal/negotiation skills.
- Experience producing R&D analysis/reporting deliverables (data, analyses, tables, graphics, listings).
- Ability to lead and work independently at a project level.