Data Analysis Standards Specialist

2 weeks ago

Toronto, Canada Sai Infotech Full time

Background:
Looking for a Data Standards Specialist with proven experience in data analysis and reporting using Roche and CDISC ADaM standards and ability to collaborate with cross-functional stakeholders at the molecule/indication project level (PDD and beyond).

Main responsibility will be to develop ADaM specifications to support standard analyses at the TA/indication level, in collaboration with cross-functional SMEs within the Pharma Data Governance Biomedical Domain.

As Biomedical Data Standards Specialist (BDSS), your main responsibilities are to:

- Develop analysis dataset (ADaM) specifications to support standard analyses at the TA/indication level, in collaboration with cross-functional SMEs within the Pharma Data Governance Biomedical Domain
- Develop standard TLG template and endpoint derivation specifications, also in collaboration with Pharma Data Governance SMEs
- Maintain analysis standards metadata in GDSR for use in our clinical trials, data marts and technology projects (e.g., Project Botany-Orchid Garden, Frictionless Insights-Admiral)
- Collaborate with other BDSS from DSG and cross-functional SMEs from PD, gRED, pRED and Medical Affairs under the Pharma Data Governance Framework to develop beginning-to-end standards from data collection to data analysis, in one or more disease areas

Skills/Experience:

- Senior ADS with extensive experience in data analysis and reporting, leading molecule programs (establishing project/molecule standards) or filing- Understanding the usage of Knowledge Graphs (or ability to adopt the technology) is helpful as the GDSR metadata is stored in graph- Proficiency in R strongly desired; could help bridge Orchid Garden and Admiral

This role comes with endless opportunities to enhance your leadership skills and broaden your impact, contributing to continuous improvement of our internal work processes and tools. As a group DSG helps drive a culture based on FAIR data principles across the Roche organization.

Must Have Skills
- Well versed in CDISC ADaM standards
- Solid experience in statistical programming for data analysis and reporting, establishing project/molecule standards, or filing
- Communication and effective stakeholder interaction

**Job Type**: Fixed term contract

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Toronto, ON: reliably commute or plan to relocate before starting work (required)

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