Principal Statistical Programmer

Parexel; Newton (MA); Remote; USD 120,000 - 180,000; Full time

Job summary

A leading clinical research organization seeks a Principal Statistical Programmer. You will provide technical support for clinical trial programming, ensuring quality and efficiency. This role involves monitoring project timelines and liaising with various teams to advance clinical studies.

Qualifications

• Experience: 7 years in statistical programming.
• Bachelor’s degree or equivalent experience required.
• Ability to lead and advise on statistical programming.

Responsibilities

• Provide technical support for statistical programming in clinical trials.
• Monitor quality, timelines, and budgets for programming projects.
• Lead teams and liaise with sponsors and other functional areas.

Skills

Programming and reporting process

FDA 21 CFR Part 11 regulations

ICH-GCP, CDISC, WSOP guidelines

Data analysis from clinical trials

SAS/BASE, SAS/STAT, SAS/SQL

Leading teams in statistical programming

Education

Bachelor’s degree in Statistics, Mathematics, Pharmaceutical Science, Data Analytics

Job description

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Name of Employer: Parexel International LLC

Position Title: Principal Statistical Programmer

Position Location: 275 Grove Street, Newton, MA 02466

Hours: Full Time / 40 hours

Summary of Duties: Provide technical support and expert advice to internal and external sponsors on statistical programming projects to support clinical trial activities. Work independently to support various programming activities related to analysis and reporting of clinical study data. Fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas. Monitor quality, timelines, resource allocation, and productivity in relation to budget. Project management for statistical programming. Advise and negotiate statistical programming timelines.

Education requirements: Bachelor’s degree in Statistics, Mathematics, Pharmaceutical Science, Data Analytics or related field of study. Employer will accept post-secondary academic coursework and/or relevant work experience which is evaluated as equivalent to a U.S. Bachelor’s degree in accordance with 8 CFR

• 214.2(h)(4)(iii)(D).
  
  

Experience requirements: 7 years of progressive experience in statistical programming.

Special Skills or Other Requirements: Applicants must have demonstrated experience with:

• Programming and reporting process.
• FDA 21 CFR Part 11 regulations;
• ICH-GCP, CDISC, and WSOP guidelines;
• Analyzing data from Phase I, II, and III clinical trials;
• SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Step, Proc Step, and Functions;
• Generating reports, tables, and listings for statisticians;
• Building structured, CDISC, SDTM or ADaM databases for clinical studies; and
• Leading teams in a statistical programming environment.
• 100% Remote reporting to Newton, MA.
  
  

*Position eligible for Employee Referral Program*

To apply: Individuals interested in applying for the position may email a resume with Job #LV0209 to [e-mail].

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care

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