Principal Statistical Programmer (Remote)

Everest Clinical Research Services Inc; Toronto; Remote; USD 100,000 - 130,000; Full time

Job summary

A clinical research organization is seeking a Principal Statistical Programmer to lead projects and ensure quality in statistical programming. Candidates should have extensive experience in SAS programming and statistical analysis, along with leadership skills. This role can be performed on-site or remotely from the USA, offering a dynamic environment for skilled professionals. Join the team to contribute to high-quality deliverables in clinical trials.

Qualifications

• 10 years of related experience with M.Sc., M.A. / 9 years with Ph.D.
• Deep knowledge of clinical trial data processing and regulatory requirements.
• Proficiency in SAS programming and regulatory submission processes.

Responsibilities

• Lead projects with complex statistical programming.
• Coordinate study teams and oversee timelines.
• Perform hands-on statistical programming and validation.

Skills

SAS programming

Statistical analysis

Leadership

Process design

Education

M.Sc., M.A., or higher in Statistics, Biostatistics, Computer Science

Job description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada, with additional sites in Bridgewater, New Jersey, USA; Taipei, Taiwan; and Shanghai (Pudong Zhangjiang New District), China.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength… that’s us… that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our team as Principal Statistical Programmer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

Key Accountabilities :

1. Lead projects with higher complexity and challenges. Resolve complex statistical programming issues.
2. Coordinate study teams, oversee timelines, assign tasks, interact with clients, and ensure quality deliverables.
3. Assist in planning and resource allocation based on project timelines, skills, and availability.
4. Maintain and develop clinical trial data and programming standards in line with industry and regulatory requirements.
5. Perform hands-on primary statistical programming and validation on various projects including clinical trials, regulatory responses, publications, etc.
6. Create SDTM and ADaM specifications and perform QC reviews.
7. Create define.xml files and perform QC reviews.
8. Conduct third-level QC reviews on programming deliverables.
9. Review regulatory submission documents and datasets for quality and compliance.
10. Lead programming efforts for drug development programs or client clusters as needed.
11. Provide training, mentorship, and guidance to less experienced programmers or biostatisticians.
12. Monitor adherence to data and programming standards and SOPs.
13. Represent the company in interactions with sponsors regarding programming projects.
14. Contribute to the development of policies, SOPs, and guidelines.
15. Participate in project bidding and bid defense meetings.
16. Coordinate archival and transfer of programming datasets and outputs upon project completion.

Qualifications and Experience :

1. M.Sc., M.A., or higher in Statistics, Biostatistics, Computer Science, or relevant fields.
2. 10 years (M.Sc., M.A.) / 9 years (Ph.D.) of related experience.
3. Deep knowledge of clinical trial data processing, analysis, and regulatory requirements.
4. Proficiency in SAS programming, statistical analysis, and regulatory submission processes.
5. Understanding of data standardization and its implications in trial data management and reporting.
6. Strong leadership, technical judgment, and process design skills.