Assoc Director, Biostatistics

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

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Job Description

POSITION OVERVIEW

As a Biostatistics/Data Science leader you will design develop and implement statisticalworkflows and solutions that support drug development and other key business use cases across Gilead. Your work will emphasize building efficient scalable and compliant statistical frameworks data pipelines automated processes and reproducible R-based tools. You will oversee version control and collaborative coding workflows on GitHub ensuring rigorous software engineering standards robust code quality and seamless integration into existing enterprise data infrastructures.

You will be instrumental in leveraging open-source software development best practices within a pharmaceutical context including familiarity with Pharmaverse packages and the unique challenges of regulated environments. Additionally you will partner with internal stakeholders and IT to ensure alignment with infrastructure requirements maintain data governance and compliance standards and foster a culture of data-driven efficiency and continuous improvement.

A successful candidate will be a strong technical project manager and a hands-on statistics/data science leader comfortable overseeing complex R package initiatives coordinating cross-functional teams and ensuring high standards of reproducibility transparency and scalability.

KEY RESPONSIBILITIES

Strategic Leadership & Cross-Functional Collaboration:

• Collaborate with statisticians on complex methodological issues ensuring appropriate statistical approaches are selected adapted and implemented for clinical trial settings.

• Translate advanced statistical concepts into robust reproducible R code that can be applied to study data including simulation studies innovative trial designs and novel estimation techniques.

• Serve as a statistics/data science leader shaping department-level standards tools and methodologies for data-intensive projects.

• Collaborate closely with study teams engineers product managers and other stakeholders to identify and implement efficient data workflows that accelerate R&D and other business operations.

• Provide thought leadership in defining short- and long-range technical roadmaps for statistics and data science initiatives ensuring alignment with organizational strategies.

• Effectively manage code repositories workflows pull requests and CI/CD pipelines to maintain code integrity and streamline development processes.

• Act as the primary technical project manager for complex R package development tasks ensuring timely delivery version control testing and documentation.

Solution Architecture & Infrastructure Coordination:

• Define and guide solution architectures for data workflows integrating R package development and open-source tools into enterprise data pipelines.

• Work with technical teams and business partners to identify and implement cloud database and infrastructure components that support large-scale secure and compliant solutions.

• Drive continuous improvement in data modeling automation data formatting and performance optimization applying pharmaceutical industry best practices and regulatory considerations.

Technical Excellence & Innovation:

• Develop and validate statistical software implementations of methodologies used in clinical trials ensuring alignment with regulatory expectations and reproducibility standards.

• Oversee the design deployment and maintenance of data workflows that emphasize automation reproducibility and consistent standards.

• Lead the development and maintenance of custom R packages ensuring adherence to industry standards and leveraging tools from the Pharmaverse ecosystem.

• Champion modern high-performance storage formats cloud-based architectures and distributed computing technologies to manage large datasets effectively in a regulated environment.

• Implement strategies for efficient data pipelines focusing on data ingestion cleaning transformation validation and quality control.

Operational Management & Compliance:

• Ensure all data engineering deliverables including R packages and automated workflows adhere to best practices corporate policies and relevant regulatory requirements.

• Identify cross-project synergies and opportunities for standardization developing reusable code components and frameworks that align with Pharma open-source initiatives.

• Manage resource planning and investments to support the execution of the data engineering strategy and ongoing initiatives.

BASIC QUALIFICATIONS

• Bacehlors Degree and 10 years experience

OR

• Masters Degree and 8 years experience

OR

• PhD and 5 years experience

Preferred Qualifications:

• PhD in Statistics Biostatistics Computer Science Information Systems or a related field with 8 years of relevant experience; or

• MS in a related discipline with 10 years of experience; or

• BS in a related discipline with 12 years of experience.

• Prior experience in pharmaceutical or life sciences domains is highly desirable.

Technical & Leadership Experience:

• Experience consulting with statisticians on complex methodological issues and translating statistical theory into practical validated software solutions.

• Proven ability to implement statistical methods (e.g. adaptive designs Bayesian methods survival models multiplicity adjustments) in clinical trial workflows using R.

• Extensive experience with R programming and developing complex R packages including testing documentation and dependency management.

• Demonstrated experience using GitHub for version control issue tracking code reviews and CI/CD to ensure high-quality maintainable codebases.

• Strong background in data engineering practices pipeline development data cleaning data validation and efficient ETL processes.

• Experience with Pharmaverse packages and familiarity with open-source development workflows for clinical trials.

• Nice to have: Proficiency in additional programming languages (e.g. Python SQL html javascript) and distributed computing frameworks.

• Nice to have: Experience building and managing AWS-based data pipelines for R.

KNOWLEDGE SKILLS & ABILITIES

• Expert knowledge in statistics/data science and software development principles for R package development in a pharmaceutical context.

• Advanced knowledge of GitHub workflows branching strategies and CI/CD tools with a track record of success in highly regulated environments.

• Ability to bridge the gap between statisticians and programmers ensuring statistical rigor is maintained while producing scalable production-quality software.

• Strong problem-solving abilities algorithm design experience and comfort handling complex projects at scale.

• Adaptable and flexible able to manage multiple priorities and pivot as needed within a dynamic compliance-driven setting.

• Excellent communication skills with the ability to present complex technical concepts to varied audiences including executive stakeholders and regulatory personnel.

• Demonstrated leadership including influence without authority conflict resolution and effective team coaching.

• Strong organizational and project management abilities with a proven record of delivering high-quality results on schedule and within scope.

ADDITIONAL REQUIREMENTS

• Ability to travel as needed.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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