Senior Manager, 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 remotely anywhere in the USA as a Senior Manager, Statistical Programming or in our Bridgewater, New Jersey, USA on-site location,

Key Accountabilities :

Coach, mentor, develop, 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 develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.

Participate in the development and maintenance of standards for database design by defining standard database modules, variable names, attributes, and associated data validation / logical checks

Participate in the development and maintenance of standards for SAS datasets of clinical trial data, including but is not limited to, raw and derived datasets from Everest databases or acquired from sponsors or 3rd party vendors.

The dataset standards will address standardization in dataset structure and names, variable attributes and definitions, documentation such as files of dataset define.doc.

Perform a leadership role in statistical programming and reporting with focuses on planning and execution of programming tasks involving standardized summary tables, listings, and graphs using established standard mockups and SAS programs / macros.

When required this effort will cover all standard and non-standard subject data listings and graphs, as well as SAS logical checks and batch editing of clinical trial data.

This leadership role will involve in the planning, leading, assessing, project management and reporting the progress status of the assigned projects, and contributing to the performance evaluation of project team members.

Lead programming efforts for assigned client clusters.

Provide mentorship and technical supervision to the statistical programming project team members of responsible projects.

Monitor the compliance of and adherence to the established standards by reviewing the programs and outputs from the project team members assigned to the responsible projects.

Follow up on the industry trends in data and programming standardization, 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.

Participate in the development of statistical programming SOPs, guidelines, and good working practices.

Assist in recruiting and developing of statistical programmers.

Provide initial orientation training to Statistical Programmers and Biostatisticians.

Lead the efforts to plan and execute archiving of the statistical programming information upon completion of the project and transfer of the archives to the sponsor.

Perform the job accountabilities of a Principal Statistical Programmer, and assist statistical programming management in managing statistical programming projects, interacting with clients, and providing day to day close supervision of statistical project team members.

Lead projects with higher level of complexity / challenges / difficulties. Lead efforts to resolve complex statistical programming issues or problems.

Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning, and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.

Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability.

Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.

Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.

Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.

Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.

Perform 3rd level QC review on programming deliverables before their release to the clients.

Perform QC review / assessment on regulatory submission programming documents, datasets, tables / listings / graphs (TLGs), and computer programs, etc.

May lead programming efforts for drug development programs or for assigned client clusters.

Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.

May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses.

Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.

Participate in statistical programming project bidding or bid defense meetings.

Work with document management specialists / archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects.

Perform transfer of the archived files to the clinical trial sponsors.

Qualifications and Experience :

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

Minimum 9 years' experience with in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.

Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.

Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.

Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations.

Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required.