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Functional Overview & Responsibilities

Our Global Statistical Sciences department includes over 200 people with advanced degrees in Statistics/Biostatistics. Our diverse population of global talent brings innovation to every aspect of our business - from Discovery Research to Clinical Development to Manufacturing and Real-world Evidence. We are playing a leading role in transforming the way the company develops medicines using state-of-the-art methods in adaptive designs, Bayesian statistics, causal inference, genetic/biomarker analysis, machine learning and more!

The Clinical Project Statistician (Advisor - Statistics) develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database, determining the appropriate statistical analysis procedures, and for analyzing data for clinical studies.

Responsibilities:

The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.

Statistical Trial Design and Analysis

• Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.

• Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created.

• Collaborate with data sciences in the planning and implementation of data quality assurance plans.

• Keep up to date with novel statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.

• Influence team members regarding appropriate research methods

• Perform peer-review of work products from other statistical colleagues.

• Communication of Results and Inferences

• Collaborate with team members to write reports and communicate results.

• Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.

• Respond to regulatory queries and interact with regulators.

• Therapeutic Area Knowledge

• Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

• Regulatory Compliance

• Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.

• Statistical leadership and Teamwork

• Introduce and apply innovative methodology and tools to solve critical problems

• Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.

• Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.

Basic Qualifications

• Currently enrolled in and attending graduate school, and will complete a Ph.D. degree in Statistics OR Biostatistics

• Expected graduation by August 2026

• Additional Functional Job Skills & Preference

• Proficient in statistical programming languages/software such as SAS, R, Python, etc

• Interpersonal communication skills for effective customer consultation

• Teamwork and leadership skills

• Technical expertise and application with working knowledge of experimental design and statistical analysis

• Self-management skills with a focus on results for timely and accurate completion of competing deliverables

• Resource management skills

• Creativity and innovation

• Demonstrated problem solving ability and critical thinking

• Business process expertise associated with critical activities (e.g. regulatory submissions)