Principal SAS Programmer

Job Posting: Principal Statistical Programmer (Contractor)

Location: Remote

Position Summary: We are seeking a highly skilled and experienced Principal Statistical Programmer (Contractor) to lead clinical studies and integrated analyses. This individual will also provide guidance and training to junior team members while contributing to statistical analysis plans and supporting the Biometrics team's collaborative efforts. The role requires proficiency in SAS programming and strong experience with clinical trial data analysis, along with an understanding of CDISC standards and FDA submissions.

Key Responsibilities:

• Lead clinical studies and integrated analyses, providing guidance and training to lower-level personnel.
• Develop and evaluate software tools, SAS macros, and utilities to automate programming tasks and facilitate collaboration within the Biometrics team.
• Contribute to the development and implementation of statistical analysis plans and provide expertise in protocol development, case report form design, and data collection.
• Review key documents such as Data Management Plan, Data Transfer Plan, Data Validation Plan, and Edit Check Specifications, offering insightful comments.
• Collaborate closely with Biostatistics to create analysis specifications based on the Statistical Analysis Plan (SAP).
• Create CDISC SDTM and ADaM files, SAS export files, Define.xml, and Reviewer's Guide for Electronic Submission.
• Conduct data and statistical analysis, generating safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
• Interact with statisticians and the clinical team, performing ad hoc analysis and generating required outputs.
• Identify issues proactively and initiate resolution of programming or data-related problems.
• Serve as a liaison between statistical programming, subcommittees, and project teams as necessary.
• Represent the organization as an external spokesperson when required.
• Develop or acquire tools to enhance programming efficiency and ensure quality control.
• Stay current with industry trends, best practices, and continuously improve statistical programming methodologies.
• Other duties as assigned.

Professional Experience / Qualifications:

• Minimum of 10 years of pharmaceutical or biotech programming experience, including experience with macro/tools development.
• FDA submission experience is highly desirable.
• Strong expertise in SAS programming and statistical analysis, with advanced skills in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat.
• Proven ability to manage multiple projects simultaneously and creatively achieve objectives.
• Solid understanding of SAS programming, Software Development Life Cycle, and CDISC standards (SDTM & ADaM).
• Familiarity with other software such as R is a plus.
• BS/MS in Statistics, Math, or a related scientific discipline.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Job ID# 511083