Director, Quantitative Lead
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Director, Quantitative Lead guiding statistical design and quantitative decision-making for clinical development programs. This senior role blends biostatistics and modeling in a modern analytical environment.
Responsibilities:
- Lead statistical design for clinical studies, including estimands, endpoint selection, sample size, and modeling approaches.
- Author or oversee SAPs and associated analysis specifications.
- Guide quantitative strategy across exploratory, interim, and confirmatory study phases.
- Lead exposure-efficacy and exposure-safety analyses using clinical exposure metrics.
- Apply statistical modeling approaches in R or Python.
- Develop simulation-based scenarios to support dose selection and benefit-risk assessments.
- Oversee blinded exploratory analyses using ARR and other metadata-driven layers.
- Guide Statistical Data Scientists in the implementation, visualization, and reproducible execution of exploratory models.
- Ensure quantitative analyses are implemented within reproducible, metadata-driven frameworks.
- Partner with Statistical Data Scientists and programming teams to translate quantitative intent into executable specifications.
- Support validation, traceability, and audit readiness of all quantitative workflows.
- Provide quantitative interpretation for study teams, governance discussions, and regulatory documents.
- Review CSRs and contribute to regulatory responses involving quantitative rationale.
- Mentor Statistical Data Scientists and Statistical Programmers on modeling, statistical methodology and interpretation.
Requirements:
- PhD or Master’s in Biostatistics, Statistics, Data Science, Applied Mathematics, or related quantitative discipline.
- 8-12+ years of quantitative experience in clinical development.
- Statistical modeling (MMRM, GLM, logistic models, Bayesian methods, longitudinal models).
- Exposure-efficacy and/or exposure-safety analyses.
- SAP authorship and study design.
- Simulation-based decision support.
- Strong proficiency in R (required); Python or Stan experience a plus.
- Familiarity with CDISC ADaM/SDTM preferred.
- Excellent communication skills with the ability to present quantitative insights to cross-functional stakeholders.
- Experience working closely with Statistical Data Scientists and Statistical Programmers.
Benefits:
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits.
- Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO, paid holidays and company-wide shutdowns.
Similar Jobs
Director of Strategic Accounts – Veterinary Corporations
Head of Corporate Accounts responsible for driving enterprise growth across corporate veterinary groups. Managing complex sales cycles and maintaining relationships with stakeholders in the pet health industry.
Health and Wellness Director
Director of Nursing at Brookdale leading the clinical team to provide high-quality care services. Building relationships and mentoring associates in a mission-driven organization.
Product Director
Product Director managing product team for strategic growth at Aspire General Insurance Company. Leading analytical insights, product development, and compliance in personal insurance sector.
Director
Empower Director leading programs on media literacy, citizenship, and civic engagement. Fostering women's empowerment as political actors under MWEG's mission.
Director, Transition – Transformation
Director leading transition and transformation projects in real estate services at Cushman & Wakefield. Ensuring operational efficiency and customer experience throughout project phases.
Client Director – Team Lead, GTS
Client Director leading strategy for global clients with substantial revenue importance. Responsible for sales growth, client relationships, and team leadership with Gartner.
Director, Channel Commerce Strategy – Distribution
Director, Channel Commerce Strategy leads Veeam’s global transactions through distributors and partners. Overseeing scalable transactions and operational efficiency for a multi-billion dollar route-to-market.
Senior Market Access & Policy Director
Sr. Market Access & Policy Director at Bamboo Health leading state-level market access strategies to improve healthcare outcomes. Collaborating with policymakers and stakeholders to expand funding opportunities.
Associate Director, Search
Associate Director, Paid Search leading a team managing paid search campaigns for pharmaceutical clients. Collaborating with internal teams to ensure successful delivery and optimization.
Director of Workforce Management
Director of Workforce Management leading strategy and continuous improvement at Convo Communications. Overseeing workforce planning and execution across interpreting services in North America.
Director of Analytics – Performance
Manage analytics and performance for Swoop's strategic healthcare clients. Leading campaign strategies and insights using advanced analytical techniques and healthcare metrics.
Director of Workforce Management
Director of Workforce Management leading workforce strategy and execution for interpreting services at Convo Communications. Focused on sustainability and operational excellence in a Deaf-owned company.
Director, Industry Intelligence – Editorial
Senior editorial leader for energy infrastructure storytelling at Neara. Responsible for guiding strategic narrative and industry insights for senior leaders.
Director of Construction
Director of Data Center Construction leading execution of AI infrastructure projects. Managing colocation builds and ensuring speed, quality, and project delivery.
Director, Clinical Data Management
Director overseeing Clinical Data Management at Definium Therapeutics, a biopharmaceutical firm. Leading CDM operations and ensuring compliance with FDA and regulatory standards.
Associate Director, Drug Product
Associate Director leading drug product development and manufacturing at CG Oncology. Ensuring robust and compliant deliverables for clinical and commercial programs.
Senior Editorial Director
Senior Editorial Director at MyHealthTeam leading content standards and AI integration. Focus on editorial excellence and team leadership in a fast-growing healthcare marketing company.
Director
Director for DEWALT overseeing North America's tools portfolio, driving growth and product launches. Collaborating cross-functionally to ensure market success and accountability across all channels.
Director, Integrated Planning, Global
Director of Integrated Planning at Deckers Brands, leading global demand and supply planning innovation. Collaborating with cross-functional teams to support supply chain efficiency and strategic initiatives.
Property Claims Director
Agriculture/Property Claims Director leading claims professionals at Reserv insurtech. Driving operational effectiveness and compliance while managing agriculture and property claims teams.