Senior Statistical Programmer

🔥 31 minutes ago

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EDETEK Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2009

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

Pharmaceuticals • Biotechnology • 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 CONFORM™ 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 — biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations — 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.

📋 Description

• Develop and validate SAS programs to generate SDTM, ADaM datasets, tables, listings, and figures for clinical trial data. • Collaborate with biostatisticians and data managers to understand project requirements and statistical analysis plans. • Perform data manipulation and statistical analyses using appropriate programming techniques. • Develop, review and critique programming specifications and outputs to ensure accuracy and compliance with standards. • Mentor and provide guidance to junior statistical programmers to enhance their skills and productivity. • Participate in the development and implementation of programming standards and best practices. • Contribute to regulatory submissions by preparing documentation and providing support during audits.

🎯 Requirements

• Bachelor's degree in Statistics, Biostatistics, Mathematics, or a related field; Master's degree preferred. • Minimum of 5 years of experience in statistical programming within the pharmaceutical or clinical research industry. • Proficiency in SAS programming; experience with R and other statistical software is a plus. • Strong understanding of clinical trial design and regulatory requirements for statistical analysis. • Experience with data management processes and data validation techniques. • Excellent problem-solving skills and attention to detail. • Strong communication skills, both verbal and written, to effectively collaborate with cross-functional teams.

🏖️ Benefits

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program