Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Summary
Provide statistical programming support to clinical trials. Produce statistical analyses, including generating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.
Primary Responsibilities
Perform all statistical programming required for clinical trial analysis and reporting
Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams
Review the Statistical Analysis Plan in preparation for programming the planned analyses
Design/develop SAS macros and other utilities to expedite SAS programming activities
Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
Participate in statistical program validation and quality control activities
Develop SDTM aCRF and specifications; complete programming and validation of CDISC SDTM and ADaM datasets
Review ADaM specification documents and ensure the specifications meet the analysis criteria specified in the SAP
Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines
Develop define.xml, study data reviewer's guide and analysis datasets reviewer's guide
Actively participate in study team meetings
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
Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management
Program data cleaning checks, as necessary, to assist Data Management's data cleaning activities
Participate in installation/validation of statistical software packages throughout the software development lifecycle
Develop and maintain the infrastructure for project files of SAS datasets and SAS code
Mentor junior level statistical programmers
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
Strong analytical skills, with the ability to process scientific and medical data.
Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros
Basic understanding of SAS/Graph
Strong problem-solving skills
Able to work independently
Excellent knowledge of statistical programming
Proficient in manipulating and analyzing SAS data
Ability to identify data issues, present problems, and implement solutions.
Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
Good organizational and time management skills, with the ability to multi-task
Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
Solid understanding of CDISC SDTM and ADaM data models
Strong interpersonal communication and presentation skills
Education or Equivalent Experience
Bachelor's degree in computer science, statistics or other related, scientific field and four years of relevant professional experience; or an equivalent combination of relevant education and/or experience.
Benefits
Why SDC
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.
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's 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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