Principal Statistical Programmer

Parexel • Newton, MA

5d • Remote

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Requirements

• Bachelor's in Statistics, Mathematics, Pharmaceutical Science, Data Analytics or related field. 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).
• 7 years of progressive experience in statistical programming.
• Applicants must have 7 years of experience with: Programming and reporting process; FDA 21 CFR Part 11 regulations; Regulatory requirements (ICH-GCP, CDISC, and electronic submissions); 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; Leading teams in a statistical programming environment; Pinnacle 21 for CDISC compliance validation; and R programming for statistical analysis and visualization.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees