Associate Director, Statistical Programming

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 (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

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 great 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 winning team as Associate Director, Statistical Programming 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.

Job Accountabilities :

Work with a Director, Senior Director, and / or Executive Director of Biostatistics / Biometrics to manage clinical trial programs / projects from one or multiple clients. Provide day-to-day technical and operational leadership to project teams supporting these programs / projects.

Represent the company and the Statistical Programming department in business development and client relationship management initiatives.

Provide leadership and oversight to the assigned client programs / projects; ensure quality, timely, and within budget deliveries.

Follow-up on the industry trends in data and programming standards and good programming working practices. Follow-up on the latest technologies, consult with clients, upper management, peers, and subordinates to evaluate, recommend, and implement improvements to the existing company standards and good working practices.

Develop and maintain clinical data and statistical reporting standards in line with pharmaceutical industry standards and conventions.

Coach, mentor, develop, and provide technical review, advice, and expertise to direct subordinate Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program / projects.

Perform semi-annual and annual performance review and create developmental plans for direct subordinates and, where appropriate, indirect subordinates by contributing to the performance evaluation process.

When required, serve as a principal level Statistical Programmer, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound / therapeutic areas levels.

Perform quality control (QC) review of statistical programming deliverables, including documentation, before they are released for production, delivered to clients, or submitted to regulatory agencies. These QC activities may include, but are not limited to, the following :

• Review and confirm SDTM dataset specifications. Perform QC activities on SDTM datasets programmed by other Statistical Programmers and Biostatisticians.
• Review and confirm ADaM dataset specifications. Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
• Perform overall review of statistical tables, listings, and figures (TLFs).
• Review and confirm define documents and reviewer’s guides for SDTM and ADaM datasets.

When required, review and provide input to clinical data management deliverables including, but not limited to, the following : electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (Plan; and the ongoing data review TLFs in accordance with the Plan), and Data Management Plan (DMP).

Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Qualifications :

Must have at least a bachelor degree and preferred to have M.Sc., M.A. or higher in Statistics, Computer Science, or relevant fields with at least 14 years of clinical research experience.

Requires demonstrated experience and success in leading statistical programming teams in planning and implementing statistical programming project plans, leading programming teams to generate and deliver quality and timely deliverables within budget.

Requires demonstrated experience implementing CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas.

Requires demonstrated experience supporting electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses.

Experience with multiple regulatory agencies preferred (FDA, PMDA, etc.).

Experience with developing and delivering training curricula and governing documents (Standard Operating Procedures, Work Instructions, Templates, etc.) preferred.

Must have an in-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.

Exceptional people management skills with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts.

Exceptional written communication and presentation skills.

Travel level specification : This position may require up to 10% business travel.