Principal Statistical Programmer

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Lead projects that involve higher levels of complexity, challenges, and difficulty.

• Address intricate statistical programming issues and challenges.

• Coordinate study teams, manage timelines, assign and monitor programming tasks, engage with clients, and ensure high-quality programming outputs.

• Assist management in planning and distributing resources based on timelines, skills, expertise, and availability.

• Develop and uphold clinical trial data and statistical programming standards.

• Conduct 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 perform QC reviews of SDTM mapping specifications and ADaM data specifications.

• Generate and conduct QC reviews of SDTM and ADaM define.xml files.

• Execute third-level QC reviews of programming outputs prior to client release.

• Evaluate and review regulatory submission programming documents, datasets, tables/listings/graphs, and computer programs.

• Lead programming initiatives for drug development programs or designated client clusters.

• Train, mentor, and provide technical support to less experienced Statistical Programmers or Biostatisticians.

• Monitor adherence to established data and programming standards and governing documents.

• Represent the company in sponsor interactions concerning statistical programming projects and related business matters.

• Develop statistical programming policies, standard operating procedures (SOPs), guidelines, and working practices.

• Participate in project bidding and defense meetings.

• Plan and execute the 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 related fields.

• 10 years of relevant experience with an M.Sc. or M.A., or 9 years of relevant experience with a Ph.D.

• Extensive knowledge of clinical trial data processing and manipulation.

• Practical experience in statistical programming and analysis.

• Familiarity with the requirements for compiling and presenting trial results to regulatory agencies.

• Understanding of industry standards for clinical trial data structure, storage, analysis, and presentation.

• Knowledge of clinical trial regulatory and ICH requirements.

• Ability to effectively plan, manage, and execute tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.

• Comprehensive understanding of standardization in data, programming, and statistical reporting of trial results.

• Strong technical judgment and experience in process design and implementation.

• Excellent leadership skills and a strong 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.