Principal Statistical Analyst

Description:

The Principal Statistical Analyst will be responsible for supporting and/or leading the statistical programming activities for clinical trial data collection, analysis, reporting, visualization on all Summit drugs. Produce, review program codes and suggest alternative solutions that may be efficient. Allocate resource for project, manage project timeline, control quality of deliverables and ensure compliance of procedure. Interact with statisticians, data management, clinicians, medical writers, medical affairs personnel, and other members of Summit regulatory.

Role And Responsibilities

Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs
Consolidate heterogeneous data source (e.g. clinical study databases, external databases, real world data) to prepare analysis-ready datasets supporting a particular project, study deliverable
Work closely with Biostatistician to implement CDISC SDTM and ADAM specification datasets
Perform compliance check and resolve any compliance issue during the process
Create documentation for regulatory filings including reviewers guides and data definition documents and ensure compliance per FDA guideline
Perform data analysis, statistical analysis, generate safety and efficacy tables, figures and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/OD
Review Data Management Plan, Data monitoring plan and edit check specification
Implement data monitoring listings and SAS edit check to support team data monitoring
Evaluate scope of work for project or ad hoc requests on resource allocation, timeline buildup, and become the stakeholder on delivery
Validate work of other programmer/analysts at CRO or in-house to ensure appropriate validation process
Create, debug, validate or maintain company level macros that streamline repetitive operations to increase programming efficiency
Act as a liaison in study team between statistical programming, and other functional teams as needed
Leads or participates in the development of standard operating procedures (SOP)
Work on improving the efficiency and quality of existing workflows and mentors Statistical Programmers and Statistical analysts
Utilize R and multiple R packages specifically for clinical trial data manipulation, statistical analysis, and reporting.
Use LLMs like Claude and GitHub Copilot to create and validate statistical programming tools and automated checks for clinical trial deliverables
Design and maintain interactive dashboards, real-time visualizations, and analytical reports with web-based frameworks
Build automation frameworks, ETL pipelines, and data workflows for both routine and ad hoc clinical data processing
Collaborate with statisticians, data scientists, and cross-functional teams to deliver solutions from data acquisition to deployment
Write reliable, reusable, and compliant production code focused on performance and scalability
Engage in all software development phases, including requirements, design, implementation, testing, deployment, and support
Containerize applications using Docker to ensure reproducibility and consistency across environments
All other duties as assigned

Experience, Education And Specialized Knowledge And Skills

Bachelor’s or Master’s degree in Biostatistics, statistics, computer science or related field
Minimum 7+ years Pharmaceutical/Biotech programming experience. Experience working with Oncology trials preferred
Solid knowledge on CDISC standards including (SDTM, ADaM)
Good understanding and hands on experience on programming support for data monitoring and data clean/query process
Good understanding on clinical data coding dictionaries (MedDRA and WHODD)
High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development
Working knowledge of current regulatory requirements and ICH guidance with deep understanding on clinical trial compliance requirements; Knowledge of Pinnacle 21
Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA, NDA/BLA or other regulatory filling experience, including ISS or ISE experience
The ability to work well under pressure and shifting priorities, both as a team leader and as a team member
The ability to plan, execute and manage project resources, timeline, and delivery with good skill on setting priorities
Ability to proactively identify and address project uncertainties to minimize risk
Strong problem solving and analytical skills
Experience with LLMs like Claude and Copilot for accelerated development and validation
Skilled in designing analytical dashboards, reporting tools, and user interfaces for clinical/scientific data
Built automation solutions, ETL pipelines, and data transformation workflows using modern programming practices
Proficient with Docker and containerization for application deployment
Knowledgeable in web technologies: React.js, Node.js, RESTful APIs, PostgreSQL, SQLite
Familiar with CI/CD and versioned deployment for rapid releases
Strong skills in Git, including branching, code reviews, and collaboration
Implemented unit/integration testing and validation for analytical apps and pipelines
Fluent in multiple programming languages (R, Python, SQL), choosing suitable tools as needed
Apply modular design, code reuse, performance optimization, and maintainability best practices
Ability to communicate clearly both oral and written