Job Description

Manager, Statistical Programming

Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS.

Summary:

Oversee a team of 5-10 statistical programmers; manage SAS programming timelines and resources and assist with personal development, training, and performance reviews. Provide statistical programming support to clinical trials by producing statistical analyses, including generating SDTM datasets, ADaM datasets, and tables, listings, and figures for clinical trials. Develop and maintain the infrastructure for project files of SAS datasets, SAS code, and supporting files. Support Data Management in dataset creation/transfers, integrity checks, and quality audits. Support business development and project management with strategic planning, proposals, pricing, and timeline planning.

Primary Responsibilities

• Manage statistical programming activities involved in the conduct and analysis of data from clinical trials conducted by SDC
• Supervise staff, both permanent and temporary, to include assignment of work, allocation of resources, SOP compliance, monitor quality and management of timelines to ensure contractual obligations and objectives are met
• Effectively manage a department and clinical study budgets for statistical programming support
• Serve as a consultant with internal and external cross-functional areas regarding operations and processes
• Optimize SAS programming processes and tools
• Represent the statistical programming department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
• Assist in the development of AI and machine learning algorithms for SDTM specifications and datasets
• Lead the design/development of SAS macros and other utilities to expedite SAS programming activities
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
• Function in the role of Senior SAS Programmer on clinical trial(s) as required:
• Create mapping and programming/validation for SDTM and ADaM datasets
• Create Define.xml, blankcrf.pdf, and associated documents
• Generate tables, listings, and graphs per the protocol, Statistical Analysis Plan, and/or approved client requests
• Participate in statistical program validation and quality control activities
• Develop code for complex data checks and data listings to assist Data Management activities
• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects
• Ensure all programming activities and processes performed are conducted according to SDC's standard procedures and/or sponsor requirements
• Adhere to all aspects of the SDC's quality system; comply with SDC's data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

Required Skills:

• Good leadership, organizational, and time management skills, with the ability to multi-task
• Skilled in analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
• Solid management background, with a track record of successfully leading a team of SAS programmers
• Experience with mentoring and training junior SAS programmers
• Excellent knowledge of statistical programming processes in clinical trials
• Experience manipulating and analyzing SAS data, with proficiency in SAS/Base, SAS/Stat, SAS Macros, and SAS/Graph
• Familiarity with CDISC standards and implementation of those standards, primarily SDTM, ADaM, and Define.xml
• Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11
• Ability to identify issues, present problems and solutions, and execute solutions
• Strong interpersonal communication and presentation skills

Education or Equivalent Experience

Bachelor's degree in computer science, statistics or other related, scientific field and eight years of relevant professional experience with experience in a management or leadership role; or an equivalent combination of relevant education and/or experience.