CDISC is seeking a Digital Transformation Analyst to drive the strategic implementation of digital standards and initiatives that accelerate the adoption and application of CDISC standards. As part of the 360i initiative, CDISC is transitioning to linked digital standards, starting with study design. This role will play a critical part in advancing this transition by leading the development, adoption, and integration of digital standards, starting with the Unified Study Definitions Model (USDM), to enable data interoperability, streamline processes, and advance digital transformation across the pharmaceutical industry. The ideal candidate will have pharmaceutical industry experience, expertise in CDISC standards, and a strong understanding of digitalization tools and techniques. They should have hands-on experience with digital models and understand how protocol information is used downstream. This role will support the transition from manual interpretation of study protocols and standards to a digital protocol and standards-driven, interoperable digital data flow. Strong collaboration skills with developers and the ability to apply software development concepts are essential.
Location: Remote
Salary: Annual salary US $105,000 - $125,000
Reports to: VP of Data Sciences
Position Type: Exempt, Full-Time
Responsibilities:
- Lead the development, enhancement, and implementation of digital standards, starting with the USDM.
- Identify and prioritize digital transformation opportunities, conducting thorough analysis and business case development.
- Develop and implement proof-of-concept solutions leveraging standards, automation, data exchange technologies, and AI/ML applications.
- Collaborate cross-functionally with internal data science, standards, and engineering teams to drive digital standards implementation.
- Partner with external stakeholders, including regulatory agencies, technology vendors, sponsors, and CROs, to advance CDISC standards adoption.
- Lead and manage digital transformation projects from initiation to completion, ensuring timely and successful delivery.
- Mentor and guide technical teams in the effective application of digital standards.
- Perform other duties as assigned.
Minimum Qualifications:
- Bachelor's degree in computer science, informatics, information management, public health, or a related field, or equivalent combination of education and experience.
- Minimum 5 years (10 years preferred) of experience in the pharmaceutical industry.
- Experience with clinical data standards, such as USDM, CDASH, and SDTM.
- Experience with digital transformation initiatives and data interoperability strategies.
- Understanding of end-to-end clinical development processes, solutions, and data flows.
- Proficiency with data modeling tools, techniques, and modeling languages.
- Strong ability to influence, motivate, and collaborate effectively.
- Proven ability to translate technical concepts for non-technical stakeholders.
- Strong strategic thinking and problem-solving skills.
- Demonstrated success in planning, executing, and managing complex projects.
- Ability to work independently in a highly agile environment.
- Experience managing complex projects using tools like Jira or ZenHub.
- Familiarity with documentation/collaboration tools like Confluence and Slack.
- Experience in cross-functional collaboration within matrixed organizations.
- Ability to travel up to 10% of the time.
Physical Activities:
This position is primarily sedentary. Work will be conducted in a standard office environment, requiring the ability to operate office equipment such as a keyboard.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Email Applications to hr@cdisc.org