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. Job Location: 275 Grove Street, Suite 101C, Newton, MA 02466 and position may telecommute from anywhere in the United States 5 days per week. Job Title: Statistical Programmer II Duties: Parexel International LLC seeks a Statistical Programmer II reporting to headquarters in Newton, Massachusetts to conduct statistical programming. Use programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings in compliance with CDISC standards. Provide technical expertise for clinical trials and support programming activities related to analysis and reporting of clinical study data. Assist in project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Create define.xml files and reviewer guides for inclusion in regulatory submissions. Use efficient programming techniques to quality control low-medium complexity derived datasets, tables, figures, and data listings. Produce Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, and publications. Assist in the production and quality control of derived dataset specifications and other process supporting documents and submission documentation. Implement statistical analysis plans (SAPs) by writing SAS code. Provide training and mentorship to staff and project teams. Maintain all supporting documentation for studies in accordance with SOPs and guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs, guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal and external audits and regulatory inspections. Participate in process/quality improvement initiatives and work with P21 Enterprise version. Position may telecommute from anywhere in the United States 5 days per week. Annual salary: $115,790.20 - $132,400. Requirements: Bachelors degree in Statistical Programming, Mathematics, Statistics, Data Analytics, Business Administration, or a related field plus 5 progressive years of statistical programming experience. Must have five years of experience in each of the following: (1) Developing and validating SAS programs for clinical trial data analysis, including data cleaning, data integration, and report generation; (2) Creating and maintaining Analysis Data Model (ADaM) datasets in compliance with CDISC standards; (3) Producing Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, and publications; (4) Implementing statistical analysis plans (SAPs) by writing SAS code; (5) Performing quality control checks on SAS programs and outputs produced by other team members; (6) Maintaining, and utilizing standard SAS macros and tools, including Base, Stat, Macro, EG, Studio, Graph, ODS, and Report; (7) Creating define.xml files and reviewers guides for inclusion in regulatory submissions; (8) Working with ICH-GCP and 21 CFR Part 11. To apply, please send resume to openings@parexel.com and cite requisition number 00979 or apply at jobs.parexel.com. This position is subject to the companys Employee Referral Program. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the worlds 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 healthcares 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.
