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Director – Biostatistics
Confirmed live in the last 24 hours
San Bruno, CA, USA
Experience Level
Desired Skills
Google Cloud Platform
  • PhD with 8-10 years, or MS with 10-12 years of proven experience in academia or industry. Pharmaceutical/biotech industry experience preferred
  • Strong knowledge of theoretical and applied statistics
  • Experience with multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data; experience running simulations and mixed models
  • Hands-on ability to drive and lead statistical strategies for clinical development of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/BLA submissions
  • Demonstrated success in leading the statistical strategy, analysis and design of a clinical development program
  • Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
  • Advanced programming skills in SAS and/or R and other relevant statistical software solutions
  • Ability to code programs to analyze and report complex clinical trial data, as well as for electronic review, exchange, transformation, and submission of data in CDlSC, SDTM and ADaM formats
  • Strong application of innovative study designs and developing landmark criteria (e.g. Go/No Go criteria)
  • Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and data modeling is strongly preferred
  • Salary Range:
  • Define how you will contribute to Alector's overall 3-5 year vision to continually improve our clinical development strategy
  • Collaborate with internal and external stakeholders in the optimized clinical study design, endpoint selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
  • Execute protocols, statistical analysis plans, and study reports, ensure statistical integrity of presentations and publications of clinical studies
  • Support the project and clinical study teams including but not limited to the derivation of go/no-go criteria, generation of data visualizations and summary reports, and interpretation of results to support internal decision-making
  • Participate in regulatory interactions (IND/CTA filings, annual safety reporting) and responsible for biostatistics input into study protocols and clinical study reports
  • Review study randomization specifications, oversee outsourced development of analysis data and results; and review case report forms while managing workflow to ensure quality, prioritization, and timeliness across multiple programs
  • Manage external vendors and serve as a key Biostats liaison with external organizations
  • Participate in establishing and maintaining policies, standards, and guidance for Biostatistical operations
  • Lead Biometrics & Digital Science Department Initiatives
  • Ensure up to date knowledge of industry and academic developments in the Neuroscience, Immuno-Oncology, and Orphan disease fields and apply to clinical study design and analysis

51-200 employees

Company Overview
Alector is combining state-of-the-art antibody technology and recent discoveries in neuroimmunology and human genetics to develop novel.