We are looking for a technically accomplished biostatistician who enjoys solving complex methodological challenges, building new capabilities and translating statistical expertise into meaningful outcomes for clients to join our Psychometrics and Statistics team as Director, Biostatistics. This role will play a pivotal role in developing and leading patient-reported outcomes (PROs) and clinical outcome assessments (COAs) statistical methodology.
As Director, Biostatistics, you will shape how we approach PRO/COA statistical methodology, helping clients generate and present evidence that meets the evolving expectations of HTA bodies and regulators across Europe and the US.
This is a hands-on leadership role. You will combine deep technical expertise with people management, taking a leading role in complex statistical analyses while developing the tools, processes and standards needed to establish a scalable, high-quality service. You'll have significant autonomy to shape the function, influence its direction and help determine how we deliver this work for our clients.
Alongside building our internal capabilities, you will work collaboratively with colleagues across the business to identify opportunities, develop client solutions and contribute to the growth of our statistical services.
Responsibilities include:
Technical Leadership & Statistical Analysis
- Lead and personally deliver complex statistical analyses of patient-reported outcomes and clinical outcome assessments, including analyses supporting Joint Clinical Assessments and post-hoc analyses of US clinical trials.
- Apply advanced statistical methods to PRO/COA data, including mixed models for repeated measures (MMRM), responder analyses, time to deterioration (TTD) and approaches to addressing missing data.
- Develop and justify minimal important difference (MID) thresholds to support the interpretation of clinically meaningful treatment effects.
- Apply appropriate estimand frameworks and approaches to intercurrent events in line with ICH E9(R1) principles.
- Provide senior statistical input into analytical strategy, study interpretation and evidence generation, ensuring methods are scientifically robust and aligned with relevant regulatory and HTA expectations.
- Establish and evolve the PRO/COA statistical methodology within the Psychometrics and Statistics team, setting technical standards and defining best practice.
Building Tools, Processes & Infrastructure
- Develop reusable, scalable analytical tools in R to improve the efficiency, consistency and reproducibility of statistical analyses.
- Design and implement statistical workflows, quality control processes and documentation standards that support high-quality, compliance-ready and audit-ready delivery.
- Establish standardised approaches, templates and procedures to support consistent project delivery as the capability grows.
- Take ownership of solutions from concept through implementation, identifying opportunities to improve analytical efficiency, quality and scalability.
Regulatory & HTA Expertise
- Maintain a strong understanding of evolving regulatory and HTA expectations for PRO/COA evidence across key jurisdictions.
- Interpret the requirements of the EU HTA Regulation (EU) 2021/2282 and associated JCA methodological guidance, including implications for clinical endpoints, patient-reported outcomes and evidence synthesis.
- Apply knowledge of national HTA requirements, including those of NICE in the UK, IQWiG/G-BA in Germany and HAS in France, recognising how country-specific expectations can influence analytical approaches and evidence interpretation.
- Ensure statistical methods reflect relevant guidance from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the International Council for Harmonisation (ICH).
- Translate complex methodological and regulatory requirements into clear, practical recommendations for project teams and clients.
Team Leadership & Development
- Lead and develop Biostatisticians, providing technical guidance, coaching and ongoing support for their professional growth.
- Foster a culture of methodological rigour, collaboration, continuous improvement and knowledge sharing.
- Act as the senior technical escalation point for complex statistical challenges, providing clear direction and sound methodological judgement.
- Help build the team's expertise and capacity as our PRO/COA statistical offering develops.
Client Engagement & Business Development
- Partner with colleagues to understand client needs and translate them into appropriate statistical approaches and clearly defined project deliverables.
- Contribute to project scoping, resource planning, timelines and budget estimates for statistical workstreams, including JCA-related engagements.
- Support proposal development, including the preparation of statistical methodology and technical content, and participate in client presentations and bid discussions.
- Represent Lumanity's biostatistics capabilities in client-facing discussions, communicating complex technical concepts clearly and confidently.
- Identify opportunities to expand our services and strengthen our position in the evolving PRO/COA and HTA landscape.
