About the Role
A senior, hands-on statistical role within Biometrics. The Director will personally lead statistical strategy and execution on assigned ophthalmology studies and contribute to cross-programme methodology and innovation. Technical leadership and hands-on delivery are at the heart of the role. Close partnership with Clinical Development, Regulatory, Data Management, and Statistical Programming is essential.
Responsibilities
- Act as lead statistician end-to-end on assigned studies, personally driving design, analysis, and interpretation.
- Author statistical sections of protocols, SAPs, and regulatory documents, including estimand framework, sample size, and analysis methodology.
- Hands-on application of MMRM, mixed models, longitudinal analyses, multiple imputation, and Bayesian approaches where justified.
- Design and interpret sensitivity and supplementary analyses aligned with ICH E9(R1).
- Perform and QC statistical analyses directly; review outputs at code and dataset level as needed.
- Support health authority interactions and author statistical content for briefing documents.
- Oversee CRO/FSP statistical deliverables from a technical standpoint.
- Champion modern statistical computing (SAS, R, Python) and AI-enabled analytics.
Qualifications
- PhD in Statistics or Biostatistics preferred; MSc with equivalent experience considered.
- Significant and proven biostatistics experience in pharma, biotech, or CRO.
- Demonstrated lead-statistician experience, ideally including ophthalmology or a therapeutic area with imaging- and function-based endpoints.
- Deep fluency in ICH E9 / E9(R1), longitudinal methods, missing-data approaches, and multiplicity control.
- Strong hands-on proficiency in SAS and R; familiarity with modern data platforms a plus.
Attributes
Rigorous, pragmatic, delivery-focused, and patient-centred. A hands‑on doer who enjoys being close to the data and the methodology. A clear communicator, curious about new methods and tools, and committed to the highest standards of scientific quality.
Equal Opportunities
At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.
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