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Senior Statistical Lead

1 month ago

Cambridge, Massachusetts, United States Global Channel Management Full time

About the job: Senior Statistical Lead

The ideal candidate will have 10 years of experience in Pharmaceutical/Biotech programming, with a focus on macro/tools development. This role requires strong SAS programming and statistical background skills, including expertise in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat. Additionally, experience with FDA submission, software development life cycle, and CDISC standards (SDTM & ADaM) is highly desirable.

The successful candidate will have a solid understanding of programming languages, software development methodologies, and data analysis techniques. They will also possess excellent communication and leadership skills to guide junior team members and contribute to project success.

Key Responsibilities:
  • Lead clinical studies and integrated analyses, providing guidance and training to junior personnel.
  • Develop or evaluate software tools, SAS macros, and utilities to automate programming activities and support Biometrics team collaboration.
  • Contribute to statistical analysis plans and provide additional expertise in the analysis of clinical trials.
  • Review Data Management Plan, Data Transfer Plan, Data Validation Plan, and Edit Check Specifications, providing comments as necessary.
  • Work closely with Biostatistics to create analysis specifications following the instructions provided in the Statistical Analysis Plan (SAP).
Requirements:
  • Minimum 10 years of experience in Pharmaceutical/Biotech programming, including macro/tools development.
  • Strong SAS programming and statistical background skills.
  • FDA submission experience is highly desirable.
  • Solid knowledge of SAS Programming language, Software Development Life Cycle, and CDISC standards (SDTM & ADaM).
  • BS/MS in Statistics, Math, or a Scientific Discipline.
Salary:

$120,000 - $180,000 per year, depending on experience.