Role: Data Scientist
The DSD Data Curation and Integration Pod collaborates extensively across our Pharma R&D organization (e.g. with pRED, gRED, Dia, FMI, Flatiron) to make it easier to manage and share data to maximize its value for R&D insights and for our patients. This effort is creating a diverse set of data mart assets to enable new analysis opportunities to accelerate the generation of meaningful scientific insights to support more efficient clinical trials, faster filings, and large-scale analyses needed to realize Roche’s personalized healthcare vision.
The Data Scientist works across the PDD insights delivery organizations, has a good knowledge of data from a variety of sources ( e.g. clinical trials, real world data), and can quickly learn and understand various data modalities (e.g. high dimensional biomarker data). The Data Scientist works closely with peers, internal and external partners and stakeholders (e.g. Biostatistician, Clinical Scientist, Biomarker Scientist, Bioinformatics etc.), has a good understanding of the analysis plan, and molecule and disease indication knowledge in order to harmonize and integrate highly complex clinical and high dimensional biomarker data to create data mart data products.
Summary of Main Responsibilities:
• Lead and contribute to a use case data mart, interacting with members of the use-case team to assess requirements for ADaM dataset creation. Expected to be the subject matter expert for ADaMs in their use-case
• Lead in the development and QC of pooled ADaM datasets
• Develop and maintain ADaM specifications ensuring consistency with Roche Data Standards where possible, with the ability to deal with the ambiguity of data usage beyond the regulatory environment
• Work closely with the SDTM curator using the analysis data requirements to guide the SDTM delivery, fostering an exchange of ideas and ensuring internal standards are met
• Develop software to support pooling of clinical trial data
• Analyze business processes, develop, test and validate standard software solutions to support these processes.
• Establish, promote and maintain strong effective working relationships with partners and stakeholders
• Is responsible for acting in line with legal, regulatory and company standards and codes of practice (e.g. Roche Code of Conduct, applicable Roche directives, guidelines and SOPs)
• Complete all required training modules as a priority
Professional and Technical Requirements:
• University Education in Biological, Data or Computer Sciences, Statistics, Mathematics and at least 5 years experience in working with ADaMs.
1. Relevant technical experience in database management systems and programming
2. Good planning and organizational skills
3. Highly flexible with a systematic and goal-oriented working style
4. Effective team work and interpersonal skills (globally, internal and externally)
5. Demonstrated leadership capabilities around decision-making, negotiation, motivation (self and others) and influencing.
6. Effective verbal and written communication skills
1. Excellent knowledge in the development and implementation of complex data manipulation algorithms
2. Good knowledge in the programming of analyses
3. Good knowledge in the principles of software design
4. Strong knowledge of CDISC data standards
5. Excellent knowledge of data modeling and relevant standard data models used to capture
clinical study data
6. Good knowledge of the drug development process
7. Good knowledge of GCP and regulatory guidelines
8. Good knowledge of methods used to analyse clinical study data
9. Fluency in written and spoken English
10. At least 5 years experience in programming using SAS, R or other statistical software packages
11. At least 5 years experience in programming of analyses of clinical study data
12. Experience as application developer, process analyst and/or application manager.