Associate Director, Biostatistics

  • Contract
  • Gaithersburg,Maryland

SimulStat

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Hybrid (on-site required 3 days/week) 6-month contract, with potential to renew

Title: Statistician

Key role within Global Technical Operations, focused on providing expert statistical and data analytical expertise. This position emphasizes a strong foundation in biostatistics, with additional skills in data science and AI being highly desirable. Working under the guidance of the Digital Transformation Lead, who oversees data, digital, and systems for Global Technical Operations, this role integrates biostatistics within the organization to deliver innovative solutions and support strategic business transformation in the biopharmaceutical industry.

Key Responsibilities:

Biostatistical Expertise:
* Provide expert biostatistical guidance in the planning and execution of projects requiring advanced analytics and data visualization tools.
* Ensure scientifically sound development strategies that incorporate current best practices and innovative statistical approaches.
* Lead the application of statistical methodologies, including mixed-models, multivariate methods, categorical data analysis, and Bayesian methodologies.
* Partner with subject matter experts (SMEs) or consultants for complex statistical work while focusing on uplifting the entire organization to enable self-serve capabilities for basic statistical tasks.
Data Science, Machine Learning and AI Integration:
* Assist in the design and delivery of data science and AI solutions and models to support biostatistical analysis and broader organizational needs.
* Develop and maintain an end-to-end data repository to enable the use of analytical methods and machine learning techniques for pattern recognition and insight generation.
* Stay current with advancements in data science and AI, applying relevant techniques to enhance biostatistical analysis.

Collaboration and Communication:
* Collaborate with scientists and process teams to provide expertise on experimental design, data analysis, and interpretation tailored to project needs.
* Develop experimental hypotheses and design computational pipelines and data visualization capabilities.
* Build strong relationships with key stakeholders, effectively communicating the value proposition of biostatistics and fostering a culture of data-driven decision-making.

Innovation:
* Implement innovative projects internally or with external resources to improve products or processes.
* Continuously evaluate and enhance existing biostatistical and data science capabilities, identifying opportunities for optimization and innovation.

Education:

PhD in biostatistics, statistics, or a related field with 10+ years of experience, or an MS or Bachelor’s degree with 15+ years of experience in the pharmaceutical or biotechnology industry.

Technical Skills:

* Deep understanding of biostatistical methods including mixed-models, multivariate methods, categorical data analysis, Bayesian methodologies, etc.
* Proficiency with statistical software (R, SAS required; JMP, MatLab, Python highly desirable).
* Database programming (SQL required; Oracle, VBA, .NET, AWS SageMaker knowledge is desirable).
Domain Knowledge: Understanding of life sciences, preferably in a pharmaceutical environment with subject matter knowledge of bioproduct CMC development.

Communication Skills:

* Ability to communicate complex issues in a simple way, translating strategy into action.
* Excellent written and verbal communication, business analysis, and consultancy skills.
* Strong interpersonal skills, conflict management, and negotiation skills.
* Ability to develop important relationships with key stakeholders and influence decision- making.

Key Accountabilities:

* Lead the application of biostatistical models to extract actionable insights and drive strategies and tactics.
* Influence end-to-end delivery of biostatistical insights, from framing the business question, designing the solution, and delivering recommendations.
* Foster collaboration and ensure seamless integration of biostatistical initiatives across the organization’s infrastructure.
* Champion innovation and facilitate the adoption of new capabilities at scale.

Experience in comparability analysis, cpv, stability desired.

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