Job Description

Statistics & Data Corporation (SDC) is a specialized data service and strategic scientific contract research organization (CRO) that has been providing solutions for pharmaceutical, biotech, and medical device/diagnostic research trials since 2005.
SDC delivers top-tier clinical trial services and technologies to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. We are committed to providing experienced teams who will take ownership of your needs and are positively engaged in your projects. With strategic consulting, biometric services (biostatistics, data management) and technology solutions (EDC, IRT/RTSM, eSource, data analytics/warehousing) expertise at our core, our services are scalable to provide seamless full service clinical trial solutions. www.sdcclincal.com
Associate Director, Statistical Programming Job Summary Oversee and manage team of statistical programmers including hiring, retention, performance reviews and professional development. Manage statistical programming resources and ensure on time, quality deliverables. 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 process improvements and standardization within the statistical programming and biostatistics workflow. Primary Responsibilities

• Manage statistical programming activities involved in the conduct and analysis of data from clinical trials conducted by SOC
• 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 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 Al 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:

o Create mapping and programming/validation for SDTM and ADaM datasets o Create Define.xml, blankcrf.pdf, and associated documents o Generate tables, listings, and graphs per the protocol, Statistical Analysis Plan, and/or approved client requests o Participate in statistical program validation and quality control activities o 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 statistical programmers
• Experience with mentoring and training junior statistical 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
• Expertise with CDISC standardsand 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, presentproblems and solutions, and execute solutions
• Focus on quality and developing/implementing quality systems for statistical programming
• Strong interpersonal communication and presentation skills

Education or Equivalent Experience

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