Remote Principal Statistical Programmer

Global Channel Management, Inc; Cambridge (MA); Remote; USD 120,000 - 150,000; Full time

Job summary

A leading biotech company is seeking a Remote Principal Statistical Programmer with 10 years of experience in Pharmaceutical/Biotech programming. The ideal candidate should have strong SAS programming skills and experience with FDA submissions. Responsibilities include managing projects, developing software tools, and leading clinical studies. This role offers flexibility and the opportunity to contribute to important clinical research initiatives.

Qualifications

• 10 years of Pharmaceutical/Biotech programming experience.
• Strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Experience in managing multiple projects.

Responsibilities

• Lead on clinical studies and integrated analyses.
• Develop software tools and SAS macros.
• Create CDISC SDTM and ADaM files for Electronic Submission.

Skills

SAS programming

Pharmaceutical/Biotech programming

FDA submission experience

Statistical background

Project management

Education

BS/MS in Statistics, Math or Scientific Discipline

Tools

SAS

SpotFire

R Shiny

Job description

About the job Remote Principal Statistical Programmer

Remote Principal Statistical Programmer needs 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.

Remote Principal Statistical Programmer requires:

• Minimum 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
• FDA submission experience is highly desirable.
• Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Ability to use professional concepts to achieve objectives in creative and effective ways.
• Experienced in managing multiple projects.
• Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
• Solid knowledge of other software such as SpotFire, R Shiny etc. is a plus.
• BS/MS in Statistics, Math or Scientific Discipline.
• Lead on clinical studies and integrated analyses and provide guidance and training to other lower level personnel.
• Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
• Contribute and implement to statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection.
• Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
• Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP).
• Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission.