Principal Statistical Programmer

Job not on LinkedIn

🕒 5 days ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $112k - $175k / year

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Lead projects with higher level of complexity/challenges/difficulties • Lead efforts to resolve complex statistical programming issues or problems • Perform a leadership role in statistical programming projects • Assist statistical programming management in properly planning and allocating resources • Participate in developing and maintaining clinical trial data and statistical programming standards • Perform hands on primary statistical programming and validation programming on assigned projects • Create SDTM mapping specifications and ADaM data specifications • Perform quality control (QC) review of these documents prepared by others • Create SDTM and ADaM define.xml files • Provide training, mentorship, and technical guidance to less experienced Statistical Programmers

🎯 Requirements

• M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields • 10 (M.Sc., M.A.)/9 (Ph.D.) years’ related experience • in-depth knowledge of clinical trial data processing and manipulation • hands on statistical programming and analysis • knowledge of industry standards • regulatory and ICH requirements • proficiency in SAS programming • in-depth understanding of standardization in data, • strong leadership and drive to achieve goals

🏖️ Benefits

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • a 401(k) retirement • generous paid time off and sick leave • the opportunity to earn a performance based bonus