Associate Director Civil Structural Engineer at AtkinsRéalis leading complex civil structural design for UK infrastructure. Collaborating with a multidisciplinary team on innovative projects in energy, defence, and nuclear sectors.
About the role
- Director of Biostatistics overseeing Patient Reported Outcomes analysis at Regeneron. Collaborating across departments and ensuring statistical rigor and regulatory adherence in drug development.
Responsibilities
- Lead and oversee the end to end process of PRO support from data collection to data analysis within BDM in collaboration with HEOR team ensuring statistical rigor and appropriateness, and regulatory adherence and HTA requirement fulfillment.
- Create, develop and refine PRO statistical analysis plans (PRO SAP)
- Contribute to PRO analysis section in the protocol and clinical study SAP when applicable, authoring technical documents, including statistical analyses plans, programming specifications and TFL mock shells.
- Establish and guide modeling expertise in various PRO instruments under different trial designs.
- Conduct appropriate statistical analyses and convey findings to internal and external stakeholders.
- Apply fit for purpose statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
- Work collaboratively with statistical programming and provide detailed and timely guidance towards the planned analyses, overseeing vendor selection, contract, budget and project management.
- Manage the PRO team and mentor junior staff, promoting knowledge sharing, continuous learning, and an innovative and collaborative environment.
- Serve as the primary contact for PRO analysis for HEOR team and lead statistical efforts on PRO with BDM, managing timelines, resources, budgets, contracts, vendors, and coordination across departments and external stakeholders.
Requirements
- PhD in statistics/biostatistics/epidemiology/health economics with at least 8 years of experience (or MS with at least 13 years of experience)
- Expertise in advanced statistical methodology to support PRO endpoints or different endpoints common to PROs.
- Expertise with analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials).
- Experience in Oncology/Hematology/Rare Diseases/PRO analysis is highly desired
- Expertise in statistical methods to support Health Economics and Outcomes Research including patient reported outcomes (including development/validation/analysis/interpretation)
- Strong experience as study/trial biostatisticians and in statistical methods to support randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials, etc.
- Experience estimating and planning resource needs and allocation, and vendor management.
- Knowledge of current statistical methods and SAS/R to solve statistical problems.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave) for eligible employees at all levels
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