Principal SAS Programmer

Location: Remote, NC  [Remote]
Employment Type: Direct Hire
Job ID: 7750
Date Added: 09/26/2022

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Client seeking a Principal SAS Programmer

KEY RESPONSIBILITIES include (not an exhaustive list of duties):

• Input into and negotiate statistical programming timelines.
• Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
• Monitor project resourcing, project budgets, and identify changes in scope
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
• Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsors
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities
Skills

• Proficiency in SAS
• Knowledge of the programming and reporting process
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
• Strong leadership skills
• Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
• Excellent analytical skills
• Effective time management in order to meet daily metrics or team objectives
Education
• Educated to degree level in a relevant discipline and/or equivalent work experience

Language Skills
• Excellent communication skills both verbal and written

Required skills and experience:

• 7+ years proficiency in SAS programming
• 2+ years of ADaM, CDISC or SDTM
• Lead experience in a Pharma setting
• Attention to detail, ability to be self-driven and solid organization skills
• Excellent communication skills (verbal and written)

KEY RESPONSIBILITIES

• Input into and negotiate statistical programming timelines.
• Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
• Monitor project resourcing, project budgets, and identify changes in scope
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
• Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsors
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities
Skills
• Proficiency in SAS
• Knowledge of the programming and reporting process
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
• Strong leadership skills
• Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
• Excellent analytical skills
• Effective time management in order to meet daily metrics or team objectives
Education
• Educated to degree level in a relevant discipline and/or equivalent work experience Masters Degree
Language Skills
• Excellent communication skills both verbal and written

Required skills and experience:
• 5-7 plus years proficiency in SAS programming
• 2+ years of ADaM, CDISC or SDTM
• Lead experience in a Pharma setting
• Attention to detail, ability to be self-driven and solid organization skills
• Excellent communication skills (verbal and written)