Summit Therapeutics, Inc.

Principal Statistical Analyst

Summit Therapeutics, Inc.

full-time

Posted on:

Location Type: Office

Location: Palo Alto • California • United States

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Salary

💰 $175,000 - $205,000 per year

Job Level

Lead

About the role

  • 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
  • Work closely with Biostatistics to implement statistical analysis of clinical trial data
  • Consolidate heterogeneous data source to prepare analysis-ready datasets supporting a particular project
  • Perform compliance check and resolve any compliance issue during the process
  • Create documentation for regulatory filings including reviewers guides and data definition documents
  • Perform data analysis, statistical analysis, generate safety and efficacy tables, figures, and listings using SAS

Requirements

  • 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
  • Knowledge of Pinnacle 21
  • Pharmaceutical experience with clinical trials, including NDA/BLA or other regulatory filling experience
Benefits
  • Bonuses
  • Stock options
  • Benefits
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS programmingMacro developmentstatistical analysisdata analysisprogramming supportdata monitoringdata cleaningcompliance checkdata visualizationCDISC standards
Soft Skills
communicationproject managementquality controlproblem-solvingcollaboration