Statistician

Lumanity•Boston, MA

5d•Hybrid

About The Position

The Patient-Centered Outcomes (PCO) team at Lumanity is seeking a Statistician to join our growing statistics group. This position can be based in the US (preferred), with flexible working arrangements; UK or EU considered. We are looking for candidates with a proven track record in life sciences consulting and expertise in applying advanced statistical methods to patient-reported outcomes (PROs).In this role, you will: Design and execute statistical analyses for PRO data in standalone studies Conduct post-hoc analyses of clinical trial data to uncover additional value in study treatments Translate complex statistical results into evidence that meets regulatory, clinical, and payer expectations Serve as a trusted advisor to clients and stakeholders on PRO statistical strategies within drug development pipelines This is a career-growth opportunity, with the hiring title determined by experience. You will start by contributing statistical expertise under the guidance of senior leaders, progressing to independently managing the full research pipeline, from study design through data analysis to final reporting.

Requirements

Master’s degree or higher in Statistics or Biostatistics, with 3–5 years of experience in a life sciences consultancy.
Statistical Expertise for PROs: Proficiency in methods tailored for skewed, bounded, longitudinal, and missing PRO data, including: Mixed Models for Repeated Measures (MMRM), Analysis of Covariance (ANCOVA), Logistic Regression, Non-parametric tests (e.g., Wilcoxon Rank-Sum), Multiple Imputation or likelihood-based methods for missing data, Sensitivity analyses for post-hoc scenarios
Regulatory Knowledge: Comprehensive familiarity with frameworks that guide statistical methods for PROs, including: FDA’s Patient-Focused Drug Development Guidance Series and disease-specific guidances, HTA Coordination Group JCA Dossier guidance, EMA’s Reflection Paper on patient experience data, ICH E9(R1) Statistical Principles for Clinical Trials: Addendum on Estimands and Sensitivity Analysis, FDA’s 2017 draft guidance on Estimands in Clinical Trials
Technical Skills: Proficiency in R, including packages for longitudinal and categorical data analysis, and the wider tidyverse suite, Experience working in a regulated programming environment
Documentation & Reporting: Skilled in preparing statistical analysis plans and technical reports using standardized templates to ensure efficiency and consistency.
Soft Skills: Exceptional written and verbal communication skills, with the ability to translate complex statistical concepts into clear, actionable insights for diverse audiences, Strong problem-solving abilities and adaptability in fast-paced environments, Skilled in partnering with clients during high-stakes projects, balancing responsiveness with scientific rigor, Proven ability to collaborate respectfully and effectively within cross-functional, mixed-methods research teams
Innovation: Experience leveraging emerging AI tools to scale statistical programming and enhance scientific writing efficiency.

Nice To Haves

Experience also designing and analyzing Discrete Choice Experiments (DCE) and other stated-preference methodologies (e.g., Best-Worst Scaling, Conjoint Analysis) to quantify patient preferences and inform product development and market access strategies is sought, though not required for this job.

Responsibilities

Design studies using non-interventional data or devise statistical approaches to analyze PROs in interventional studies, enabling robust and meaningful insights.
Develop detailed statistical analysis plans, execute data analyses, interpret findings, and prepare clear, comprehensive reports.
Conduct post-hoc analyses of clinical trial data to identify additional treatment benefits or insights related to PROs.
Compile and author statistical sections of COA dossiers, integrating evidence to support regulatory and market access submissions.
Maintain strong Sponsor relationships by delivering scientifically rigorous analyses designed to meet client and program needs, balancing methodological precision with practical decision-making.