Principal Statistical Programmer

Company: PAREXEL
Location: South Bend
Posted on: January 16, 2022

Job Description:

Be part of our empowered Parexel Statistical Programming team today!


Principal Statistical Programmer (with SDTM experience) - to contribute to meaningful advances that benefit patients in need.

Location - Home based US


As a Principal Programmer you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. Parexel will provide you with the perfect opportunity to expand on your experiences and develop new skills in a stimulating work environment


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 activitiesQualificationsSkills
  
• 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 objectivesEducation
• 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)EEO DisclaimerParexel is an equal opportunity employer. - Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, South Bend , Principal Statistical Programmer, IT / Software / Systems , South Bend, Indiana