
201 - 500 employees
Founded 2009
đ Pharmaceuticals
đ§Ź Biotechnology
âïž SaaS
Pharmaceuticals âą Biotechnology âą SaaS
EDETEK Inc. is a clinical development informatics company that provides a cloud-native R&D Cloud ecosystem and an integrated eClinical platform to support clinical trials and regulatory submissions. Its product portfolio includes CONFORMâą orchestration and collaboration tools, an eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), data integration and metadata hubs, a clinical data lake, and statistical computing and submission-ready environments. EDETEK also offers services â biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations â targeting pharmaceutical, biotechnology, and medical device sponsors. The company emphasizes interoperability, data quality, and AI-enabled capabilities to accelerate study execution and regulatory submissions globally.
đ July 27
đ Ukraine, United States, +6 more countries â Remote
â° Full Time
đ Senior
đ„ Software Engineer
đ» Ghost score 18%
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201 - 500 employees
Founded 2009
đ Pharmaceuticals
đ§Ź Biotechnology
âïž SaaS
Pharmaceuticals âą Biotechnology âą SaaS
EDETEK Inc. is a clinical development informatics company that provides a cloud-native R&D Cloud ecosystem and an integrated eClinical platform to support clinical trials and regulatory submissions. Its product portfolio includes CONFORMâą orchestration and collaboration tools, an eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), data integration and metadata hubs, a clinical data lake, and statistical computing and submission-ready environments. EDETEK also offers services â biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations â targeting pharmaceutical, biotechnology, and medical device sponsors. The company emphasizes interoperability, data quality, and AI-enabled capabilities to accelerate study execution and regulatory submissions globally.
âą Develop and validate SAS programs to generate SDTM, ADaM datasets, tables, listings, and figures for clinical trial data. âą Collaborate with biostatisticians and data managers to understand project requirements and statistical analysis plans. âą Perform data manipulation and statistical analyses using appropriate programming techniques. âą Develop, review and critique programming specifications and outputs to ensure accuracy and compliance with standards. âą Mentor and provide guidance to junior statistical programmers to enhance their skills and productivity. âą Participate in the development and implementation of programming standards and best practices. âą Contribute to regulatory submissions by preparing documentation and providing support during audits.
âą Bachelor's degree in Statistics, Biostatistics, Mathematics, or a related field; Master's degree preferred. âą Minimum of 5 years of experience in statistical programming within the pharmaceutical or clinical research industry. âą Proficiency in SAS programming; experience with R and other statistical software is a plus. âą Strong understanding of clinical trial design and regulatory requirements for statistical analysis. âą Experience with data management processes and data validation techniques. âą Excellent problem-solving skills and attention to detail. âą Strong communication skills, both verbal and written, to effectively collaborate with cross-functional teams.
âą Choice of comprehensive Medical, Vision and Dental Insurance plans âą Paid vacation time and sick days âą Corporate holidays annually âą Participation in the 401K Plan âą Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. âą Health Advocate and Employee Assistance Program
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