Director of Biostatistics – Real-World Evidence
About the Role
We are seeking an experienced Director of Biostatistics for a leading international biopharma developing treatments for serious neurological, endocrine and neuropsychiatric disorders. This individua will provide strategic and technical leadership across Real-World Evidence (RWE), Health Economics and Outcomes Research (HEOR), and epidemiology studies.
This is a high-visibility opportunity to become the first person on the ground in Europe for Biostatistics, shaping the function and capability from scratch, with close exposure to senior leadership and US-based teams.
The successful candidate will act as the overall statistical lead and primary Biometrics representative, partnering closely with Medical Affairs, HEOR and other cross-functional departments to develop and execute RWE strategies. This will include protocol development, statistical analysis planning, implementation of analyses, interpretation of findings and dissemination through publications.
You will serve as the analytical methodology expert across RWE study designs and data analyses, ensuring scientific rigour across a range of real-world data types and applications.
Key Responsibilities
- Act as statistical lead and represent Biometrics across health outcomes and epidemiology studies.- Provide strategic and tactical support for cross-functional RWE development, supporting regulatory, payer and clinical stakeholders.- Serve as a subject matter expert in RWE/HEOR research design, methodologies, data sources, analytical techniques and reporting.- Leverage administrative claims, electronic medical records and other real-world data sources to recommend optimal study designs.- Select and implement appropriate analytical methodologies, including statistical and machine learning models, aligned with wider business objectives.- Develop high-quality study protocols, statistical analysis plans, study reports and supporting documentation.- Ensure the quality, scientific rigour and consistency of analytical deliverables.- Identify opportunities for innovation in the application and utilisation of real-world data.- Build effective relationships with internal stakeholders to establish when and how RWE can best support development and business strategies.- Collaborate with and manage external vendors to ensure project timelines, deliverables and objectives are achieved.
Required Experience and Expertise
- Extensive expertise in Real-World Evidence, biostatistics, epidemiology or a closely related discipline.- Demonstrated experience evaluating and developing RWE strategies, from initial conceptualisation through to practical application.- Experience leading the design and execution of observational research, including protocol development, statistical analysis plans and study reports.- Experience across different RWE applications, including early-stage clinical development, regulatory approvals and payer, HTA and healthcare provider engagements.- Knowledge of global regulatory and Health Technology Assessment (HTA) requirements for RWE.- Extensive experience working cross-functionally with Medical Affairs, Health Economics and other relevant stakeholders.- Hands-on experience with prospective and retrospective observational studies.- Experience leading secondary data analyses using medical claims, electronic medical records, chart reviews and registries.- Strong leadership capabilities, including the ability to mentor and coach scientists and lead indirect or multidisciplinary teams.- Excellent organisational skills, with a proven ability to manage multiple projects through to successful completion.- Strong competency in standard statistical software, particularly SAS or R.- Ability to interpret and communicate complex research findings effectively to internal and external audiences.- Demonstrated ability to translate strategic direction into practical operational plans.
Education and Qualifications
Candidates should hold one of the following:
- A Master's degree in Statistics, Biostatistics or a related discipline, alongside 10+ years of experience leading observational research and RWE programmes.- A PhD in Statistics, Biostatistics or a related discipline, alongside 7+ years of relevant experience.- Extensive previous leadership experience is required.
Location and Working Arrangements
- Allscwil, Switzerland.- Hybrid, 2-3 days a week onsite.- Swiss employment contract essential.
Benefits
- Bonus.- Stock Options.- Pension.- Health Insurance.- 30 days annual leave, plus additional days for national holidays.
Additional Information
- Senior-level strategic and scientific leadership position.
- Travel requirement: approximately 0–25%.