Research Advisor - Statistics

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)