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
1. Lead statistical programming activities as Trial Programmer for phase I to IV clinical studies or assigned project-level activities.2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work. Make statistical programming recommendations at study level. Contribute to project level standards3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team (CTT).4. Review eCRF, discuss data structures and participate in data review activities.5. Comply with company, department and industry standards (e.g. CDISC) and processes, review and develop programming specifications as part of the analysis plans.6. Provide input into statistical programming solutions and/or ensure their efficient implementation.7. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.10. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance12. Contributes to assigned parts of process improvement, standardization and other non-clinical initiatives1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Trial Statistician and the manager.2. Adequate representation of the Statistical Programming function as Trial Programmer in the Clinical Trial Team – effectiveness of communication and team behaviors as assessed by the team members.3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study as assessed by the manager.
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