Clinical Data Integrator

Job title: Clinical Data Integrator

Job description: Role: Clinical Data Integrator

Type: 2 Year Contract

Department: PDD

Summary of Main Responsibilities

• Lead and contribute to a use case datamart, interacting with members of the use-case team to discuss, assess requirements for ADaM dataset creation. Expected to be the SME for ADaMs in their use-case

• Lead in the development and QC of pooled ADaM datasets

• Develops and maintains ADaM specifications ensuring consistency with Roche Data Standards where possible, with the ability to deal with the ambiguity of Secondary data usage

• Working 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

• Develops software to support pooling of clinical trial data.

• Analyses business processes, develops, tests and validates standard software solutions to support these processes.

• Establishes, promotes and maintains strong effective working relationships with stakeholders

Compliance

• 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)

• Completes all required training modules as a priority

Professional and Technical Requirements

• University Education in Computer Science, Statistics, Mathematics or other field (e.g., physics, biology, pharmacology) and at least 5 years experience in working with ADaMs.

Technical Competencies

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. Effective verbal and written communication skills

Experience, Skills, Knowledge

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. Excellent knowledge of data modeling and relevant standard data models used to capture

clinical study data

5. Good knowledge of the drug development process

6. Good knowledge of GCP and regulatory guidelines

7. Good knowledge of methods used to analyse clinical study data

8. Fluency in written and spoken English

9. At least 5 years experience in programming using SAS, R or other statistical software packages

10. At least 5 years experience in programming of analyses of clinical study data

11. Experience as application developer, process analyst and/or application manager

Job Level: Individual contributor

Company: Roche

Expected salary:

Location: Mississauga, ON

Job date: Thu, 13 Jan 2022 23:16:47 GMT

Job Source: Careerjet.ca

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