Senior Nonclinical Data Standards SME; CDISC SEND​/SENDIG-AR

Senior Nonclinical Data Standards SME (CDISC SEND/SENDIG-AR)

Mission Alignment Remote May 18, 2026

Remote / DMV area preferred

Public Trust Eligible

Blu Omega is seeking a Senior Nonclinical Data Standards SME to support a federal program focused on nonclinical data standards and analytics. This role operates within a remote environment with some travel anticipated and is responsible for providing subject matter expertise in nonclinical data standards, supporting data quality and compliance management, and assisting in the development of a Nonclinical Data Coordination Center platform.

The position requires experience supporting regulatory data standards within a mission-driven environment.

Program: BARDA Nonclinical Data Standards and Analytics Support

Mission overview:
Support the development and implementation of nonclinical data standards and analytics to enhance regulatory compliance and data quality for medical countermeasure research and development.

Location:

Remote / DMV area preferred

Clearance:
Public Trust Eligible

Work Authorization: US Citizens only

Schedule:

Full-time, with some travel (up to 25%)

• Serve as technical SME for CDISC SEND and SENDIG-AR (2019) standards
• Develop validation criteria, business rules, and quality control procedures for dataset ingestion and review
• Support design and implementation of data architecture and metadata governance frameworks
• Establish data acceptance and rejection criteria aligned with regulatory expectations
• Assist in developing training and implementation plans for data standards and governance
• Ensure datasets meet regulatory requirements, including FDA Animal Rule compliance
• Review raw data from CROs for completeness and quality
• Communicate findings and troubleshoot issues with study personnel
• Support quality control workflows, including dataset review and report QC
• Provide expertise to research teams and coordinate with CRO contractors on data delivery and format requirements

• Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological or chemical sciences such as medicine, pharmacy, life sciences, immunology, molecular biology, biochemistry, microbiology, or similar
• Minimum of 8 years of relevant industry or postdoctoral experience in regulatory data standards and analytics
• Direct experience with SEND implementation, including SENDIG-AR (2019)
• Client-focused approach and ability to prioritize in a remote/hybrid environment
• Ability to work effectively with multidisciplinary teams

• Extensive knowledge of FDA/ICH guidelines and CDISC data standards
• Experience applying statistical and epidemiologic methods to nonclinical datasets
• Quality assurance and quality control experience with nonclinical data

Salary Range: $100,000 - $155,000

Final compensation is based on technical skills, experience, education, certifications, and clearance.

• Medical, Dental, and Vision coverage through national providers
• 401(k) with company match (eligible after 6 months; vesting applies)
• Company-paid Life and AD&D insurance with additional voluntary options
• Short-term disability (company-paid) and long-term disability options
• Employee Assistance Program (EAP) with 24/7 confidential support and mental health resources
• Telehealth and virtual care options available through medical plans
• Pet insurance, legal services, and identity theft protection options
• Paid Time Off (PTO) for eligible employees
• Paid federal holidays for salaried employees
• Access to wellness programs, discounts, and lifestyle benefits
• Benefits eligibility and offerings may vary based on role, employment status, and program requirements

Blu Omega is a Woman-Owned Small Business (WOSB) delivering technology and cybersecurity solutions to federal agencies and enterprise clients nationwide. Headquartered in Ashburn, VA, we support mission-critical programs across civilian and defense sectors, including health, national security, and regulatory environments. We partner with government agencies and large integrators to provide expertise in cybersecurity operations, cloud and infrastructure modernization, data and analytics, and enterprise IT support.

Our teams are experienced operating within federal contracting environments, supporting task orders, recompetes, and programs requiring cleared personnel and compliant delivery.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.