Sr. Statistical Programmer
IQVIA Holdings Inc.
Bengaluru, India
3d ago

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

The Senior Statistical Programmer is responsible for all programming aspects (including analysis datasets, pooled datasets, listings, figures, and tables) of Medical Affairs (MA) studies, non-interventional studies (NIS), and to support scientific analytic studies.

May also support individual Phase II-IV clinical trials or other project level activities for small drug project / indications (or equivalent), as agreed with customers.

Supervise CROs as required to ensure timeliness of deliverables with highest quality.

1. Responsible for the integrity of the programming / computing solutions for multiple clinical trials (or equivalent) and / or publication activities.

2. Is the scientific lead for programming expertise liaising with Statistical and clinical counterparts within the study / project team, across multiple projects

3. Is responsible for the full execution of final production output generation (tables, listings and graphics) for projects as the Trial Programmer, ensure high quality for all deliverables, and follow the processes.

May lead programming activities for a relatively small project or an indication with guidance from Subject Matter Experts (SMEs)

4. Maintain effective interfaces with internal and external customers with support of vendor management, Principal Programmer / Statistician and Group Leads as needed.

5. In conjunction with the statistician, responsible for development of programming specifications of analysis datasets and pooled datasets, study-level programming standards and ensure compliance with project-level / company standards.

With guidance, may provide support to development of project-level programming standards, following internal guidelines.

6. Ensure that study documents and specifications are consistent and comply with company standards by providing input into eCRF and data structures, tables, listings and figures for studies and submission activities.

7. Responsible for programming (according to specifications) analysis datasets, pooled datasets, listings, tables, and figures for studies and for Summary of Clinical Safety (SCS) and Summary of Clinical Efficacy (SCE) with high quality and within milestones.

8. Responsible for preparing Case Report Tabulations for the regulatory submission as required.

9. Responsible for QC compliance and archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality deliverables.

10. Review planning of edit checks; assist non-standard, complex data validation programming as needed according to agreed plans for the assigned study / project.

11. Assume the role of subject matter expert / domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance.

12. Provide input on process improvement initiatives and participate in non-programming project activities.

13. Maintain up-to-date knowledge of programming software (e.g. SAS / R / S-plus) and guide junior programmers as and when needed

14. Provide programming expertise in developing / selecting / modifying basic / intermediate MACROs for reporting standards.

15. Supervise the activities of the vendors as needed.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare.

Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

2020-06-11 00 : 00 : 00

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