As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound.
You will become a part of a team with an inherent breadth of knowledge and expertise in small, single center Investigator studies to multi-site, multi-national trials in Phases I to IV of clinical development, as well as observational studies. From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers will employ industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects.
Parexel develops and delivers cost effective, high-quality training programs for those employees that are directly involved with sponsor functional partnerships to ensure that our statistical programmers can quickly step in to make significant contributions to the success of a study. In addition, you will receive the opportunity to shape your development through quarterly conversations with your manager. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: Minimal
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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
- Team player
- Tech-Savvy
- Communicator
- Proactive
- Detail-oriented
- Analytical
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Development
Opportunity to learn and grow through a performance and development goal-setting program.
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Collaboration
Work with industry leaders and subject matter experts.
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Variety
Opportunity to work on a wide range of therapeutic areas and medical devices.
Responsibilities
Parexel is looking for a GCDS Therapeutic Area Lead! This position is full-time, remote from anywhere in the United States!
Description of Role & Responsibilities
The GCDS TA Lead is a subject matter expert in the area of data standards as it relates to developing clinical data collection tools. The individual may be responsible for coordinating data processes related to new therapeutic areas, which may require them to create standards from scratch rather than work to update or change existing standards. The GCDS TA Lead is able to work independently or as a team member or leader with equal effectiveness. The GCDS TA Lead interacts with staff across multiple sponsor sites, and mentors, guides, and provides project leadership for junior staff as assigned. The GCDS TA Lead may participate in process design and/or implementation initiatives.
Minimum FTE Years of Experience
- 8+ years’ work experience, which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development.
- Advanced knowledge and leading-edge skills in clinical data standards.
- Study Data Tabulation Model (SDTM) expertise
- InForm expertise
- Analysis & Reporting experience
- Program-level clinical and business requirements knowledge
- Communication/presentation skills
- Education/training/facilitation skills
- Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects. Knowledge of clinical data management.
Educational Requirements
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline
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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.
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