RemoteLeaf Logo
Log in Sign up

Associate Director, Biostatistics & AI

3 weeks, 3 days ago
United States
Full-time
Lead
AI (Artificial Intelligence)
Software Development
Machine Learning MLOps Python R
Apply Now
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised
View All Jobs 34

Description

  • Apply appropriate statistical methodologies to support medical insights, value demonstration, safety monitoring, and lifecycle management.
  • Contribute to statistical design, analysis, and reporting for Phase II–IV clinical trials, including adaptive designs, Bayesian methods, and estimands under ICH E9(R1).
  • Support NDA, BLA, MAA, and other global regulatory submissions as lead or co-statistician, and respond to health authority queries.
  • Design and implement AI/ML interface environments that connect SAS, R, and Python with enterprise LLM APIs, RAG pipelines, and clinical data repositories.
  • Build, test, and iterate on AI-powered tools for SAP drafting, TFL automation, anomaly detection, protocol deviation identification, and regulatory document support.
  • Establish and maintain MLOps pipelines for model development, validation, deployment, and monitoring in a GxP-compliant, audit-ready framework.
  • Implement AI governance standards including explainability, bias assessment, and 21 CFR Part 11 / EU Annex 11-compliant documentation.
  • Evaluate and deploy AI-powered automation for CDISC mapping, data cleaning, and submission package preparation.
  • Partner with IT and external vendors to integrate AI tools with EDC, CTMS, RTSM, and pharmacovigilance systems.
  • Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance to align biometrics and AI deliverables with program timelines.

Requirements

  • PhD or Master’s degree in Biostatistics, Statistics, Computer Science, Artificial Intelligence, Data Science, or a closely related quantitative field.
  • 5+ years (PhD) or 7+ years (Master’s) of pharmaceutical biostatistics experience in drug development, biotech, or CRO settings, or 3+ years of hands-on AI/ML engineering experience.
  • Expert-level proficiency in SAS and/or R, with working knowledge of Python for data science, scripting, or AI/ML development.
  • Demonstrated exposure to AI/ML tools such as LLM APIs, prompt engineering, RAG pipelines, agentic workflows, automation scripting, or MLOps infrastructure.
  • Deep knowledge of CDISC standards, including SDTM, ADaM, and Define-XML, and regulatory submission workflows.
  • Experience contributing to NDA, BLA, or MAA submissions is preferred.
  • Meaningful exposure to clinical or life sciences data, including clinical trial datasets, pharmacovigilance data, or regulated GxP environments, is preferred.
  • Foundational understanding of statistical concepts such as hypothesis testing, regression, and survival analysis.
  • Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments including FDA, EMA, and ICH.
  • Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences.

Benefits

  • Market-leading compensation with an annual performance bonus and company equity.
  • 401(k) with 100% employer match on the first 3% and 50% on the next 2%.
  • Employee stock purchase program.
  • Comprehensive health coverage with 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • Health Savings Account with annual employer contributions, plus Flexible Spending Accounts.
  • Mental health support through Spring Health, including therapy and coaching sessions.
  • Hybrid work model with a U.S.-based remote setup and quarterly office visits as needed.
  • Unlimited flexible paid time off plus company-paid holidays.
  • Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents.
  • Pre-tax commuter benefits, referral bonus, subsidized lunch on in-office days, and access to professional development programs.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Mindrift.ai: Be the “I” in AI

Civil Engineer & Python Expert - Freelance AI Trainer

Mindrift.ai: Be the “I” in AI Internet Software & Services

Mindrift is seeking part-time contributors for project-based AI opportunities to create and verify engineering problem sets that help test and improve AI systems for leading tech companies.

United States Part-time Junior AI (Artificial Intelligence)
Up to $144k
C MATLAB NumPy Pandas Python R SciPy SQL System Design
26 minutes ago
Bluelight Consulting

Agentic AI Solutions Architect - Remote, Latin America

Bluelight Consulting 11-50 Internet Software & Services

Bluelight is hiring a remote Agentic AI Solutions Architect in Latin America to lead client-facing AI solution design and deliver end-to-end agentic workflows that improve operations and drive measurable business impact.

Argentina Latin America Full-time Senior AI (Artificial Intelligence) Solutions Architect
Apache Airflow AWS Azure GCP Generative AI LLM Machine Learning MLOps Prefect Python Snowflake SQL
29 minutes ago
CrowdGen by Appen

AI Translation Evaluator; Russian-English

CrowdGen by Appen Internet Software & Services

Appen is hiring an independent contractor to evaluate Russian-English AI translations for accuracy and adherence to user-provided context and requirements.

Anywhere Contract Junior AI (Artificial Intelligence) Linguist
$42k-$42k
33 minutes ago
Mindrift.ai: Be the “I” in AI

Civil Engineer & Python Expert - Freelance AI Trainer

Mindrift.ai: Be the “I” in AI Internet Software & Services

Mindrift is seeking part-time contributors for project-based AI evaluation work that involves creating and validating engineering problems for leading tech companies.

Germany Part-time Junior AI (Artificial Intelligence)
C MATLAB NumPy Pandas Python R SciPy SQL System Design
54 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers