Biostatistician, HEOR Consulting Services

Description About The Position: Norstella's HEOR Services team is seeking an experienced biostatistician to develop statistical analysis plans and perform advanced statistical analysis on non-interventional observational research studies using real world data. This role will advise internal and external clients on recommended statistical approaches to support study research objectives, and will be directly responsible for documentation, implementation, and interpretation of statistical analysis plans. The ideal candidate brings deep expertise with realworld data, strong R programming skills, and a track record of applying advanced statistical methods to support regulatory, epidemiology, HEOR, and RWE use cases. Key Responsibilities:

• Support senior HEOR leaders with non-interventional observational research study design, advanced statistical analysis, and interpretation using NorstellaLinQ Realworld Data to support regulatory, epidemiology, HEOR, and RWE use cases.
• During study design phase, recommend appropriate statistical methods to address study research objectives (e.g., power calculations, methods to mitigate selection bias, development of matched cohorts, development of measures from multiple sources [e.g., EMR + claims], analysis of NLP-derived measures from unstructured EMR, approach for outcomes that require time-to-event analysis with competing risk, multivariable modeling, repeated measures, time-averaged clinical measures, causal inference, and techniques for analyzing rare and ultra rare populations including Bayesian statistics).
• Write statistical analysis plans to address the above considerations.
• Execute and interpret statistical analyses using R.
• Review summary tables, study reports, and publications for accuracy.

Qualifications

• Advanced degree (MS or PhD) in Biostatistics, Statistics, or a related quantitative field.
• At least 3 years of professional experience as a biostatistician/statistician using real-world data or clinical trial data in the pharmaceutical, biopharmaceutical, medical device, or CRO/consulting environment.
• Strong proficiency in statistical programming using R (technical proficiency will be tested). Additional proficiency in SQL or Python is valued.
• Ability and willingness to train and work within the Panalgo IHD analytics platform.
• Working knowledge of regulatory and methodological standards for realworld evidence, including data quality, bias mitigation, and transparency.
• Ability to succinctly communicate complex technical methods to cross-functional audiences.
• Expertise with integrated or linked datasets (e.g., registries/EMR + claims) and techniques such as target trial emulation and external control arms is highly desired.

Our guiding principles for success at Norstella: Bold, Passionate, Mission-First We have a lofty mission to Smooth Access to Life Saving Therapies, and we will get there by being bold and passionate about the mission and our clients. Our clients and the mission in what we are trying to accomplish must be in the forefront of our minds in everything we do. Integrity, Truth, Reality We make promises that we can keep, and goals that push us to new heights. Our integrity offers us the opportunity to learn and improve by being honest about what works and what doesn't. By being true to the data and producing realistic metrics, we are able to create plans and resources to achieve our goals. Kindness, Empathy, Grace We will empathize with everyone's situation, provide positive and constructive feedback with kindness, and accept opportunities for improvement with grace and gratitude. We use this principle across the organization to collaborate and build lines of open communication. Resilience, Mettle, Perseverance We will persevere - even in difficult and challenging situations. Our ability to recover from missteps and failures in a positive way will help us to be successful in our mission. Humility, Gratitude, Learning We will be true learners by showing humility and gratitude in our work. We recognize that the smartest person in the room is the one who is always listening, learning, and willing to shift their thinking.