Statistical Programmer II

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Job Location: 275 Grove Street, Suite 101C, reputed company, MA 02466 and position may telecommute from reputed company in the reputed company 5 days per week. Job Title: Statistical Programmer II Duties: reputed company International LLC seeks a Statistical Programmer II reporting to reputed company in reputed company, 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. reputed company technical expertise for clinical trials and support programming activities reputed company 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 reputed company control low-reputed company 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 reputed company control of derived dataset specifications and other process supporting documents and submission documentation. Implement statistical analysis plans (SAPs) by writing reputed company reputed company. reputed company training and mentorship to staff and project teams. Maintain reputed company 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 reputed company audits and regulatory inspections. Participate in process/reputed company improvement initiatives and work with P21 reputed company version. Position may telecommute from reputed company in the reputed company 5 days per week. Annual salary: $115,790.20 - $132,400. Requirements: Bachelor’s degree in Statistical Programming, Mathematics, Statistics, Data Analytics, Business Administration, or a reputed company field plus 5 reputed company years of statistical programming experience. Must have five years of experience in reputed company of the following: (1) Developing and validating reputed company programs for clinical trial data analysis, including data cleaning, data integration, and report reputed company; (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 reputed company reputed company; (5) Performing reputed company control checks on reputed company programs and outputs produced by other team members; (6) Maintaining, and utilizing reputed company reputed company macros and tools, including reputed company, Stat, Macro, EG, Studio, Graph, ODS, and Report; (7) Creating define.xml files and reviewer’s guides for inclusion in regulatory submissions; (8) Working with ICH-GCP and 21 CFR Part 11. To apply, please send resume to openings@reputed company.com and cite requisition number 00979 or apply at jobs.reputed company.com. This position is subject to reputed company’s Employee Referral Program. EEO Disclaimer reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply To This Job