Principal Statistical Programmer

Job not on LinkedIn

🕒 April 4

🏖️ 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 by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables • Assist statistical programming management in properly planning and allocating resources based on timelines • Participate in developing and maintaining clinical trial data and statistical programming standards • Perform hands on primary statistical programming and validation programming • Create SDTM mapping specifications and ADaM data specifications • Perform quality control (QC) review of these documents prepared by others • Perform 3rd level QC review on programming deliverables before their release to the clients • Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians

🎯 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 • An in-depth knowledge of clinical trial data processing and manipulation • Hands on statistical programming and analysis • Requirements for assembling and presenting trial results to regulatory agencies • Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented • Knowledge of clinical trial regulatory and ICH requirements • Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming • Statistical analysis and submission of trial data and results to regulatory agencies • Must possess an in-depth level understanding of the concept of standardization in data

🏖️ 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 / pension plan • generous paid time off and sick leave • the opportunity to earn a performance based bonus