Associate Director of Data Standards & Statistical Programming

Job Description

Position Summary : Associate Director of Data Standards & Statistical Programming

The Associate Director of Data Standards & Statistical Programming will be responsible for Planning and tracking the statistical programming activities including SAS macro development at both the program level and the study level. They will also be responsible for overseeing and managing the workflow of required clinical data listings, summary tables, figures, and Define.xml files on our programs. The DSSP will support the Biostatistics and data management teams with ensuring SOPs and other departmental resources remain up-to-date.

Job Description

What you'll do :

• Planning and tracking the statistical programming activities including SAS macro development at program level and study level.
• Coordinating tasks across multiple studies within a program collaborating with CRO, Biostatistics and Data management on key deliverables.
• Ensuring the latest CDISC standards are implemented and followed
• Designing, developing and validating computer programs to analyze clinical data. Defining departmental standards and SOPs as needed.
• Overseeing and managing the workflow of required clinical data listings, summary tables, figures and Define.xml files on the program.
• Mentor junior programmers assigned to the project.
• Manage all statistical programming activities at program and study level.
• Oversee the work of programmers to ensure high quality accurate results.
• Act as a liaison between statistical programming, data management, and biostatistics and plan for optimal workflow and outcomes.
• Exercise independent judgment in developing SOPs, Work Instructions and Processes to enable production of high-quality results.
• Perform statistical analysis to enable interpretation of clinical trial results.
• Create SDTM, ADaM, SAS transport files, Define.xml, Pinnacle 21 reports and reviewer guides for electronic submissions worldwide.
• Generate safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS / STAT, SAS / Graph, SAS / SQL, and SAS / ODS.
• Develop Data set specifications and review TLF Shells,
• Review Data Management Plan, Data validation plan, and edit check specifications.

Requirements :

Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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