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 activities Qualifications 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
Excellent communication skills both verbal and written
Required skills and experience:
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) EEO Disclaimer Parexel 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.