Principal Statistical Programmer

🔥 12 hours ago

🏖️ 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.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New 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

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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 levels of complexity, challenges, and difficulty • Resolve complex statistical programming issues and problems • Coordinate study teams, oversee timelines, assign and follow up on programming tasks, interact with clients, and ensure quality programming deliverables • Assist management with planning and allocating resources based on timelines, skills, expertise, and availability • Develop and maintain clinical trial data and statistical programming standards • Perform primary statistical programming and validation programming for phase I–IV clinical trials, integrated clinical summaries, regulatory agency requests, publication support, data explorations, and data monitoring committee meetings • Create and QC-review SDTM mapping specifications and ADaM data specifications • Create and QC-review SDTM and ADaM define.xml files • Perform third-level QC review of programming deliverables before client release • Review and assess regulatory submission programming documents, datasets, tables/listings/graphs, and computer programs • Lead programming efforts for drug development programs or assigned client clusters • Train, mentor, and provide technical guidance to less experienced Statistical Programmers or Biostatisticians • Monitor compliance with established data and programming standards and governing documents • Represent the company in sponsor interactions regarding statistical programming projects and related business • Develop statistical programming policies, SOPs, guidelines, and working practices • Participate in project bidding and bid defense meetings • Plan and perform archival of statistical programming datasets, outputs, documents, and final programs • Transfer archived files to clinical trial sponsors

🎯 Requirements

• M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields • 10 years’ related experience with an M.Sc. or M.A., or 9 years’ related experience with a Ph.D. • In-depth knowledge of clinical trial data processing and manipulation • Hands-on statistical programming and analysis experience • Knowledge of requirements for assembling and presenting trial results to regulatory agencies • Knowledge of industry standards for clinical trial data structure, storage, analysis, and presentation • Knowledge of clinical trial regulatory and ICH requirements • Ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies • In-depth understanding of standardization in data, programming, and statistical reporting of trial results • Sound technical judgment and experience in process design and implementation • Strong leadership and drive to achieve goals

🏖️ Benefits

• Medical coverage • Dental coverage • Vision coverage • Life & AD&D insurance • Short- and long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program (EAP) • 401(k) retirement plan • Generous paid time off • Sick leave • Opportunity to earn a performance based bonus