Principal Statistical Programmer

Bristol Myers Squibb

• $149K — $223K *
Boston, MA 02115In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a Scientific Discipline
  • 5+ years with M.S. or 8+ years with B.S. in Biotech, Pharmaceuticals, or Clinical Research
  • Proficient in SAS language, procedures, and functions
  • Intermediate knowledge of CDISC Standards and clinical trials
  • Experience with regulatory submissions
  • Effective written and verbal communication skills

Responsibilities

  • Delegates tasks and tracks progress within the team
  • Performs quality control on SAS code and outputs
  • Solves complex clinical trial reporting issues
  • Engages across functions at senior management levels
  • Creates files and analyses for electronic submissions in eCTD format
  • Ensures compliance with Vertex SOPs and FDA regulations
  • Participates in cross-functional project management teams

Benefits

  • Comprehensive medical, dental, and vision coverage
  • Generous paid time off including company-wide shutdowns
  • Educational assistance and student loan repayment programs
  • Substantial commuting subsidy
  • 401(k) with employer matching
  • Support for charitable donations
  • Flexible work arrangements: remote, hybrid, or on-site options
Full Job Description

Job Description

General Summary:

The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. In addition, the Principal Statistical Programmer is a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer.

Key Duties and Responsibilities:

  • Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools)
  • Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group
  • Demonstrates in-depth knowledge of clinical development and medical data
  • Solves complex clinical trial reporting problems and demonstrates technical proficiency and exercises judgment in supporting daily operations and ensuring that study tasks are completed accurately and in a timely manner
  • Engages with a variety of other functions, including Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data and submission-related activities, often at Senior Management levels
  • Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/ISE
  • Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations
  • Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
  • Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies

    • Knowledge and Skills:

  • Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Intermediate knowledge of CDISC Standards
  • Intermediate knowledge of clinical trials
  • Regulatory submission experiences
  • Effective communication (written and verbal) skills to explain difficult information

    • Education and Experience:

  • Bachelors degree in a Scientific Discipline
  • Typically requires 5+ for M.S. or above and 8+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization

    • Pay Range:

    $149,200 - $223,800

    Disclosure Statement:

    The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

    At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

    Flex Designation:

    Remote-Eligible

    Flex Eligibility Status:

    In this Remote-Eligible role, you can choose to be designated as: 
    1.    Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
    2.    Hybrid: work remotely up to two days per week; or select
    3.    On-Site: work five days per week on-site with ad hoc flexibility.

    Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

    #LI-Remote

    * Ladders Estimates

    Similar Jobs

    Ad banner background

    Get Ready For Your
    Next Interview

    More Jobs at Bristol Myers Squibb

    More Pharmaceuticals & Biotech Jobs

    Find similar Principal Statistical Programmer jobs:

    NationwideBoston, MA