Principal Statistical Programmer

Job not on LinkedIn

🕒 April 4

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $112k - $175k / year

⏰ Full Time

🔴 Lead

🖥 Software Engineer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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