Job Description

Associate Director, Statistical Programming

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

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.

Why SDC

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC\xe2\x80\x99s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

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Statistics & Data Corporation (SDC)