Principal Biostatistician

Role Summary

We are seeking a Principal Biostatistician to play a pivotal role in the drug development of multiple assets through designing clinical trials, determining appropriate sample sizes, and applying rigorous statistical methods to evaluate whether a treatment is safe and effective. The role will collaborate closely with clinicians, data managers, and regulatory teams to ensure that study protocols are scientifically sound and that the resulting data can withstand regulatory scrutiny. The work involves analyzing complex datasets, interpreting results in a scientifically meaningful way, and preparing statistical reports that support regulatory submissions. This role reports to the Senior Director of Biostatistics and AI/ML and is remote.

Responsibilities

• Lead statistical design and analysis for Phase I-II clinical trials and observational studies (sample size, randomization, adaptive features, estimands).
• Develop and review Statistical Analysis Plans (SAPs), protocols, interim analysis plans, and regulatory submission documents (CSR, eCTD statistics modules).
• Oversee implementation and quality control of statistical deliverables; ensure reproducible analyses and adherence to standards (CDISC SDTM/ADaM, controlled terminologies).
• Perform advanced analyses (survival, longitudinal, mixed models, Bayesian methods, multiplicity adjustments, subgroup and sensitivity analyses).
• Review vendor and CRO outputs and ensure statistical integrity.
• Contribute to SOPs, templates, methodological guidance, and cross-functional working groups.
• Communicate complex statistical concepts clearly to clinical, regulatory, and operations teams.

Qualifications

• MS or PhD in Biostatistics, Statistics, Mathematics, Epidemiology, or related quantitative field (PhD preferred).
• Typically 8+ years (MS) or 6+ years (PhD) of biostatistics experience in pharmaceutical/biotech industry.
• Demonstrated experience leading statistical design and analyses for late-stage clinical trials and regulatory submissions.
• Strong knowledge of clinical trial methodology, regulatory statistical requirements, and CDISC standards.
• Proven track record of authoring and reviewing SAPs, statistical sections of clinical study reports, and submission packages.
• Proficiency with R and other statistical software (e.g., Python, Stata).
• Experience with CDISC SDTM and ADaM standards and related implementation tools.
• Familiarity with clinical trial data capture systems and data flow (EDC, eCRF).
• Knowledge of ICH guidelines (E9, E3, E8), FDA/EMA statistical expectations, and GxP.

Skills

• Strong leadership, project management, and stakeholder engagement skills.
• Excellent written and verbal communication; ability to explain technical topics to non-statisticians.
• Critical thinker, detail-oriented, and able to work independently and collaboratively in cross-functional teams.
• Ability to manage multiple programs, timelines, and priorities concurrently.
• Experience with rare disease indications and/or pediatric populations.
• Experience with novel statistical methodology (platform trials, master protocols, adaptive designs, Bayesian frameworks, synthetic or external control arms).
• Training across analytical disciplines preferred (data science, bioinformatics, statistical programming).
• Experience implementing AI/ML algorithms for improved decision-making preferred.

Education

• MS or PhD in Biostatistics, Statistics, Mathematics, Epidemiology, or related quantitative field.