About Us:
CDISC is a nonprofit that promotes a diverse and inclusive workplace where we learn from and support each other. CDISC welcomes qualified applicants of different backgrounds, experiences, abilities, and perspectives.
With everyone contributing their unique strengths, we’re able to harness our collective power to drive more meaningful clinical research. Help us create clarity and amplify data’s impact for clinical research and global health!
We invite you to learn more about CDISC and why what we do is so important to so many. https://www.cdisc.org/about
Position Overview:
CDISC is seeking a Data Standards Lead to drive the strategic development of standards and initiatives that accelerate the adoption and application of CDISC standards. This role will play a critical part in enhancing data interoperability, streamlining processes, and advancingtransformation across the pharmaceutical industry. The ideal candidate will have experience in the pharmaceutical industry and expertise in CDISC standards.
Location: Remote
Salary: Annual salary US $55,000 - $75,000
Reports to: Director of Standards Operations
Position Type: Exempt, Full-Time
Responsibilities:
• Lead the development, enhancement, and implementation of CDISC Standards.
• Collaborate cross-functionally with internal data science, standards, and engineering teams to drive standards development.
• Working with CDISC tools such as QRS Maker, Wiki, SharePoint, and Jira to facilitate the development of standards
• Interact with external stakeholders, including regulatory agencies, sponsors, and CROs, to advance CDISC standards adoption.
• Maintain effective communication with CDISC development teams, subject matter experts, and other stakeholders.
• Participate and lead projects from initiation to completion, ensuring timely and successful delivery.
• Assist with resource planning, allocation, and coordination of project plans, deliverables, and KPIs in collaboration with the Project Management Office.
• Adhere to all CDISC policies and procedures, including the Code of Ethics and Intellectual Property Policy.
• Travel as necessary to meet with volunteers, team members, or conduct meetings.
• 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 3 years of professional experience in academic, CRO, regulatory, supporting technology, consulting vendor, or pharmaceutical settings.
• Solid understanding of clinical data standards.
• Strong understanding of end-to-end clinical development processes and data flows.
• Strong ability to communicate and collaborate effectively.
• Excellent strategic thinking and problem-solving skills to identify opportunities, develop solutions, and make sound decisions.
• Ability to work independently in a fast-moving environment.
• Experience in cross-functional collaboration within matrixed organizations.
• Ability to travel up to 5% of the time.
Preferred Qualifications:
• Master’s degree in computer science, informatics, information management, public health, or related field, or equivalent combination of education and experience.
• 5 years of professional/technical experience within an academic, CRO, regulatory, supporting technology or consulting vendor, or pharmaceutical setting.
• Proficient with CDISC standards such as Controlled Terminology, CDASH, SDTM, and ADaM.
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