Postdoctoral Medical Fellow – Applied Biostatistics, Clinical Trial Simulation

This is a fully remote position, open to applicants in United States.

📋 Description

• Integrate various multimodal data sources throughout trial operations and clinical outcomes to parameterize and calibrate simulations.

• Evaluate and validate clinical trial simulation frameworks that quantify the impact of operational and clinical factors on success probability.

• Develop simulation models that incorporate clinical trial and real-world evidence data for scenario-based planning.

• Create scenario engines for trial execution planning and translate findings into actionable decision support.

• Implement and assess statistical methods to ensure trial robustness under execution realities, including analyses of missing data sensitivity, Bayesian models, intercurrent events, estimand-aligned strategies, site-level/random effects, treatment-effect attenuation, informative dropout, and time-varying covariates.

• Conduct simulation studies to evaluate sample sizes, randomization schemes, interim decision rules, adaptive elements, and endpoint definitions.

• Assess performance metrics such as power, type I error, bias, estimation bias, predictive probabilities, and other operating characteristics.

• Develop reusable and reproducible R/Python simulation pipelines for simulation, diagnostics, and reporting.

• Maintain version-controlled, thoroughly tested, and well-documented workflows.

• Communicate findings to biostatistics, clinical operations, clinical development, and data science stakeholders through manuscripts, conference abstracts, internal whitepapers, and presentations.

• Operate with significant autonomy, taking ownership of projects with scientific guidance from supervisors and the wider team.

⛳️ Requirements

• A Ph.D. in Biostatistics or Statistics (or a closely related quantitative discipline) from an accredited institution, to be awarded before the start date.

• A solid foundation in clinical trial methodology and inference, encompassing GLMs, mixed models, survival analysis, longitudinal models, causal/estimand thinking, basic multiplicity concepts, and Bayesian experience.

• Proven ability to program in R and/or Python for statistical modeling and simulation.

• Prior experience with reproducible workflows is preferred, including Git, unit testing, code review, and literate reporting formats like Quarto, RMarkdown, or Jupyter.

• Familiarity with Monte Carlo simulation, power/operating characteristic evaluation, and principled model checking/validation.

• Interest or experience in working with multimodal trial data, including operational metrics and clinical outcomes data.

• Ability to collaborate effectively and communicate statistical results to non-statistical stakeholders in a clear and pragmatic manner.

• Demonstrated ability to work independently and manage an individual research agenda.

• Must possess legal authorization to work in the United States without restrictions.

• Willingness to undergo a drug test and post-offer physical, if required.

• Must be 18 years of age or older.

• A curriculum vitae is required.

• A letter of intent is required, emphasizing how a fellowship at Boehringer Ingelheim can enhance career growth.

🏝️ Benefits

• Competitive compensation and benefits packages.

• A healthy working environment.

• Engaging and meaningful work.

• Opportunities for mobility.

• Networking opportunities.

• A focus on work-life balance.

• Potential eligibility for role-specific variable or performance-based bonuses and/or additional compensation elements.