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Principal Statistical Programmer
応募 求人ID R0000040432 ロケーション ニュートン, マサチューセッツ州 仕事内容Name of Employer: Parexel International LLC
Position Title: Principal Statistical Programmer
Position Location: 275 Grove Street, Newton, MA 02466
Salary: $159,896.21 – $207,400 per year
Hours: Full Time / 40 hours per week
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 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).
Experience requirements: 7 years of progressive experience in statistical programming.
Special Skills or Other Requirements: 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; andR programming for statistical analysis and visualization.
*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 openings@parexel.com.