Salary Range: 250000 to 265000 (Currency: USD) (Pay period: per-year-salary)

During your first year, your goals will include:

• 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 partners in the optimized clinical study design, end point selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
• Execute protocols, statistical analysis plans, study reports, ensure statistical integrity of presentations and publications of clinical studies
• Support project team and clinical study team including but not limited to 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 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 reviewing case report forms while managing workflow to ensure quality, prioritization, and timeliness across multiple programs
• Provide statistical oversight in the development of key study documents
• 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
• Ensure up to date knowledge of industry and academic developments in the Neuroscience and Orphan disease fields and apply to clinical study design and analysis 

We’d love to hear for you if you have:

• PhD with 8-10 years, or MS with 10-12 years of proven experience in academia or industry. Pharmaceutical/biotech industry experience preferred
• Solid understanding of theoretical and applied statistics
• Experience with multiple imputation, 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
• Experience with rare disease and real world data
• 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 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 strongly preferred