Associate Director, Statistical Programming

Everest-Clinical-Research; Bridgewater Township (NJ); Hybrid; USD 170,000 - 205,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life & AD&D insurance

401(k) retirement plan

Tuition reimbursement

Job summary

Everest Clinical Research in New Jersey seeks an Associate Director, Statistical Programming to lead complex statistical programming programs for multiple trials. The role can be on-site in Bridgewater, NJ or remote from a home-based office in the USA under our Work from Home policy.

You will mentor teams, ensure quality deliverables, implement CDISC SDTM/ADaM standards, support regulatory submissions, and drive best practices across the Biostatistics/Biometrics group.

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 and delivering quality/budget-compliant results.
• Requires experience implementing CDISC standards to specify, program, and validate SDTM and ADaM datasets.
• Experience supporting electronic regulatory submissions of clinical trial data.

Responsibilities

• Lead statistical programming programs/projects for one or multiple clients.
• Provide day-to-day technical and operational leadership to project teams.
• Represent the company in business development and client relationship management.
• Ensure quality, timely, and within-budget deliverables.
• Develop and maintain SDTM/ADaM standards in line with industry conventions.
• Coach and mentor subordinate programmers and biostatisticians.

Skills

Leadership

CDISC standards

SDTM/ADaM

Regulatory submissions

Statistical programming

People management

Quality assurance

Education

Bachelor degree in Statistics/related field

Master's degree (M.Sc./M.A.) in Statistics/Computing

Job description

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 Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

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.

Benefits & Compensation

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement / pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $170,000 - $205,000.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com .

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

#INDHP

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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