Sr Statistical Programmer

1 week ago

Cranbury, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Develop, validate, and execute SAS programs for data extraction, transformation, and statistical analysis.
  • Perform complex data manipulations, including merging, sorting, and aggregating large datasets.
  • Generate tables, listings, and figures (TLFs) to summarize and present analytical results.
  • Using SAS, perform SDTM, ADaM, and table, figure, and listing (TFL) programming, quality control (QC) review, and create documentation of programs used in creating statistical outputs.
  • Follow current SDTM standards and current ADaM Implementation Guides.
  • Ensure the accuracy and consistency of data by conducting quality checks and validating analysis results.
  • Follow best practices for programming and maintain a well-documented codebase.
  • Review and QC programs and outputs generated by junior programmers.
  • Collaborate with cross-functional teams, including statisticians, data scientists, clinical researchers, and project managers.
  • Communicate effectively with team members and stakeholders to understand project requirements and deliverables.
  • Stay up-to-date with industry standards and regulatory guidelines (e.g., FDA, ICH) to ensure data integrity and compliance.
  • Contribute to the preparation of regulatory submissions by providing statistical outputs and documentation.
  • Manage multiple projects simultaneously, ensuring timelines and deliverables are met.
  • Provide mentorship and guidance to junior SAS programmers as needed.
  • Prepare and maintain documentation, including analysis plans, data dictionaries, and programming specifications.
  • ssist in the development of standard operating procedures (SOPs) related to SAS programming.
Requirements:
  • Bachelor's or Master's degree in a relevant field (e.g., Statistics, Computer Science, Life sciencess).
  • 6 -7years of experience in SAS programming, with a proven track record of working on complex data analysis projects.
  • Pharma/biotech/medical device/CRO experience.
  • Proficiency in SAS programming, including BASE SAS, SAS/STAT, SAS/MACRO, and SAS/GRAPH.
  • strong background in statistical analysis and data management.
  • Familiarity with clinical trial data and CDISC standards is often preferred.
  • Strong problem-solving skills and attention to detail.
  • Excellent communication and interpersonal skills.
  • bility to work both independently and collaboratively within a team.