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Full-Time

Biostatistics Director

Updated on 7/9/2024

Alector

Alector

201-500 employees

Develops immuno-neurology therapies for neurodegenerative diseases

Biotechnology

Compensation Overview

$250k - $265kAnnually

Senior, Expert

Remote in USA

Category
Bioinformatics
Public Health
Biology & Biotech
Required Skills
R
Google Cloud Platform
Requirements
  • PhD with 8-10 years, or MS with 10-12 years of proven experience in academia or industry
  • Solid understanding of theoretical and applied statistics
  • Experience with multiple imputation, multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data
  • Experience with rare disease and real world data
  • Advanced programming skills in in SAS and/or R and other relevant statistical software solutions
  • Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
Responsibilities
  • Provide statistical leadership and expertise in support of the clinical development activities for multiple therapeutic areas
  • Contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews, development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting
  • Apply innovative statistical approaches to the work; support and defend analyses and their interpretations in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions
  • Influence key decision-makers within the project team and within senior management to ensure a high degree of rigor to the statistical and scientific decision-making process and outcomes
  • 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

Alector Therapeutics is an excellent workplace for those interested in contributing to cutting-edge therapies in the realm of neurodegenerative diseases. With a focus on immuno-neurology, the company leverages advanced biotechnological methods to pioneer treatments that harness the body’s own immune system for healing. Their robust pipeline of programs in clinical trials demonstrates a commitment to scientific excellence and leadership in addressing complex medical challenges.

Company Stage

IPO

Total Funding

$269.5M

Headquarters

South San Francisco, California

Founded

2013

Growth & Insights
Headcount

6 month growth

2%

1 year growth

0%

2 year growth

0%