Principal Statistical Programmer

Parexel • Newton, MA

7d • 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

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