Major Activities :
1. Lead the statistical activities for a trial or publication activities.
2. Responsible and accountable for transcribing RAPs into computational solutions for the statistical programmer to implement (specifications of derived variables, specification and development of statistical computing solutions for inferential statistical analyses, tables and listings templates for the FIR and CSR) of Phase I-IV clinical trials.
3. Responsible and accountable for multiple studies RAP execution including the RAP meetings with the necessary CTT members and third party, reporting activities, exploratory analyses/ and additional analyses to support publications for individual clinical trials.
4. Ensure high quality for all assigned deliverables and processes and ensure audit-readiness.
5. Maintain efficient interfaces with internal and external customers with support of management, Lead Statistician, CROs and CPOs as needed.
6. Ensure to deliver agreed timelines for statistical deliverables.
7. Develop and comply with project / study standards and specifications following internal guidelines.
8. Provide statistical analysis solutions when exploratory analyses are required.
9. Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.
10. Participate in the selection of CROs and supervise the trial activities of the CROs as needed.
11. Support quality control and quality audit of deliverables.
12. Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH
MS (in Statistics or equivalent) with 5+ years relevant work experience or PhD (in Statistics or equivalent) with 2+ years of work experience
Fluent English (oral and written).
- Working knowledge of/experience with SAS/ R or any other business or research analytic software with an expertise in at least one software.
- Statistical and numerical knowledge and expertise in analytic aspects.
- Excellent interpersonal and communication skills
- Good understanding of global clinical trial practices, procedures, methodologies.
- Good understanding of regulatory requirements