Are you ready to lead high-impact projects in the dynamic world of clinical research? At Everest Clinical Research, we’re looking for an experienced Principal Statistical Programmer to join our team—whether remotely from home or at our Bridgewater, New Jersey office.
As a full-service contract research organization (CRO), Everest provides a broad range of clinical research services to pharmaceutical, biotechnology, and medical device industries. We work with some of the most innovative and well-known companies, contributing to the development of cutting-edge drugs, biologics, and medical devices.
With a strong reputation for quality deliverables, customer service, and flexibility, Everest is at the forefront of driving success in the clinical research field. Join us and become a part of a winning team that's making a real impact on global healthcare.
What You'll Be Doing:
- Lead Complex Projects: As a Principal Statistical Programmer, you will oversee the execution of high-complexity projects, resolving complex statistical programming challenges and ensuring top-quality deliverables.
- Guide & Mentor: Take on a leadership role by coordinating study teams, assigning tasks, and mentoring less experienced statistical programmers and biostatisticians.
- Hands-on Programming: Engage in primary statistical programming and validation for various clinical trial phases (I-IV), regulatory submissions, data explorations, and more.
- Develop and Maintain Standards: Work with industry standards to maintain clinical trial data and statistical programming standards. This includes creating SDTM and ADaM data specifications and performing quality control (QC) reviews of programming documents.
- Ensure Quality Control: Conduct 3rd-level QC reviews of programming deliverables, regulatory submission documents, and datasets before they reach the client.
- Client Interaction: Represent Everest in interactions with clinical trial sponsors and ensure the smooth delivery of programming projects.
- Continuous Improvement: Contribute to the development of statistical programming policies, SOPs, and best practices to ensure adherence to industry standards and regulatory requirements.
Qualifications and Experience We’re Looking For:
- Master’s Degree (M.Sc., M.A.) or higher in Statistics, Biostatistics, Computer Science, or related fields.
- 10+ years of hands-on experience in clinical trial data processing, statistical programming, and regulatory submission (for M.Sc./M.A. holders) or 9+ years for Ph.D. holders.
- Extensive knowledge of SAS programming, statistical analysis, and regulatory requirements for clinical trials.
- Strong understanding of SDTM, ADaM, and define.xml files, as well as clinical trial regulatory guidelines (ICH, FDA).
- Ability to lead teams, manage resources, and deliver projects within timelines while ensuring high-quality standards.
- Experience working in a collaborative, fast-paced environment and mentoring junior staff.
- Ability to develop, plan, and execute statistical programming strategies while ensuring compliance with industry standards.
Why Everest?
- Work from Anywhere: We offer the flexibility of remote work, so you can contribute from home, wherever you are in the USA, or from our office in Bridgewater, New Jersey.
- Be Part of a Growing Team: Everest is known for its strong growth and entrepreneurial spirit. You’ll be part of a supportive, forward-thinking organization that thrives on innovation.
- Make an Impact: Help bring life-changing medical solutions to the market by working on some of the most advanced clinical trials and regulatory submissions.
- Work-Life Balance: Enjoy a culture that supports flexibility and a healthy work-life balance.
- Comprehensive Benefits: We offer competitive compensation, health insurance, and other benefits to keep you and your family covered.
Join a Winning Team at Everest Clinical Research
If you're passionate about making a difference in clinical research and possess the expertise to drive high-quality statistical programming initiatives, we'd love to hear from you.
Apply today and be part of a team that values quality, flexibility, and making a difference in the world of healthcare!
Everest Clinical Research is an Equal Opportunity Employer.
We welcome applicants from all backgrounds, and we are committed to providing accommodations to individuals with disabilities throughout the recruitment process.