What are the responsibilities and job description for the Principal Statistical Analyst position at Summittherapeutics?
Job Title : Principal Statistical AnalystDepartment : Data Programming
Overview of Role :
The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.
The Principal Statistical Analyst will be responsible for supporting and / or leading the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization on all Summit drugs. The role includes producing and reviewing program codes, suggesting alternative solutions, allocating resources for projects, managing project timelines, controlling the quality of deliverables, and ensuring compliance with procedures. Interaction with statisticians, data management, clinicians, medical writers, medical affairs personnel, and other members of Summit regulatory is essential.
Role and Responsibilities :
- Work closely with Biostatistics to implement statistical analysis of clinical trial data, including 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 sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready datasets supporting a particular project or study deliverable.
- Collaborate with Biostatisticians to implement CDISC SDTM and ADaM specification datasets.
- Perform compliance checks and resolve any compliance issues during the process.
- Create documentation for regulatory filings including reviewers' guides and data definition documents, ensuring compliance with FDA guidelines.
- Conduct data analysis and statistical analysis, generating safety and efficacy tables, figures, and listings using Base SAS, SAS macros, SAS / STAT, SAS / Graph, SAS / SQL, and SAS / OD.
- Review Data Management Plans, Data Monitoring Plans, and edit check specifications.
- Implement data monitoring listings and SAS edit checks to support team data monitoring.
- Evaluate the scope of work for projects or ad hoc requests regarding resource allocation and timeline buildup.
- Validate the work of other programmers / analysts at CRO or in-house to ensure appropriate validation processes.
- Create, debug, validate, or maintain company-level macros that streamline repetitive operations to increase programming efficiency.
- Act as a liaison in study teams between statistical programming and other functional teams as needed.
- Lead or participate in the development of standard operating procedures (SOPs).
- Work on improving the efficiency and quality of existing workflows and mentor Statistical Programmers and Statistical Analysts.
- Perform all other duties as assigned.
Experience, Education and Specialized Knowledge and Skills :
The pay range for this role is $170,000-$190,000 annually. Actual compensation packages are based on several factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. This may differ in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonuses, stock, benefits, and / or other applicable variable compensation.
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Salary : $170,000 - $190,000
