01
TRCD-26-04242
Associate Consultant – CDISC ADaM (Statistical Programming) SME
Seeking a 6–8 years statistical programming SME to lead design, review, and validation of CDISC ADaM datasets (e.g., ADSL, ADAE, ADLB, ADVS, ADTTE, BDS) for efficacy, safety, and time-to-event analyses. The role includes ensuring end-to-end traceability from Protocol/SAP/SDTM to ADaM and TLFs, producing audit-ready documentation (Define-XML/reviewer guides), and supporting submission-ready programming. Additionally, the consultant will act as a human-in-the-loop reviewer for AI-generated ADaM specs and R/SAS code, improving reusable derivation guidance and governance for AI-assisted clinical programming.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Contract
- Experience
- Minimum 6 years and Maximum 8 years
Role overview
Why This Role Matters.
Seeking a 6–8 years statistical programming SME to lead design, review, and validation of CDISC ADaM datasets (e.g., ADSL, ADAE, ADLB, ADVS, ADTTE, BDS) for efficacy, safety, and time-to-event analyses. The role includes ensuring end-to-end traceability from Protocol/SAP/SDTM to ADaM and TLFs, producing audit-ready documentation (Define-XML/reviewer guides), and supporting submission-ready programming. Additionally, the consultant will act as a human-in-the-loop reviewer for AI-generated ADaM specs and R/SAS code, improving reusable derivation guidance and governance for AI-assisted clinical programming.
Your Impact
Deliver Enterprise Value
Help organisations solve complex business problems through modern technology, consulting expertise and measurable outcomes.
Collaboration
Work Across Teams
Collaborate with consultants, architects, engineers and client stakeholders throughout the project lifecycle.
Growth
Learn Continuously
Gain exposure to enterprise technologies, certifications, mentoring and real-world project experience.
Career Path
Grow With Ubique
Build a long-term consulting career with opportunities to take on greater responsibility and leadership over time.
Responsibilities
What You'll Be Doing.
Every role at Ubique contributes directly to solving meaningful business challenges for our clients.
02
Review and validate complex derivations for ADSL, ADAE, ADLB, ADVS, ADTTE, and BDS domains.
03
Ensure compliance with CDISC ADaM standards, sponsor standards, and regulatory expectations.
04
Review SAPs, protocols, mock shells, and specifications to ensure complete analytical traceability.
05
Review and approve AI-generated ADaM specifications and derivation logic.
06
Validate AI-generated R and/or SAS code and transformation outputs.
07
Act as the SME reviewer within human-in-the-loop workflows.
08
Identify ambiguities in specifications and establish reusable derivation guidance.
09
Provide expert feedback to continuously improve AI agent performance and output quality.
10
Lead dataset validation and conformance reviews.
11
Ensure traceability across Protocol, SAP, SDTM, ADaM, and TLF.
12
Drive audit-ready documentation and review processes.
Technology stack
Tools & Technologies.
The platforms and technologies you'll use to build modern, enterprise-grade solutions.
01
CDISC
Required
02
ADaM
Required
03
SDTM
Required
04
ADSL
Required
05
ADAE
Required
06
ADLB
Required
07
ADVS
Required
08
ADTTE
Required
09
BDS
Required
10
TLF
Required
11
Define-XML
Required
12
Reviewer Guide
Required
13
SAP
Required
14
Protocol
Required
15
Mock shells
Required
16
Specifications
Required
17
R
Required
18
SAS
Required
19
Pharmaverse
Required
20
Admiral
Required
Requirements
Skills & Experience.
We value curiosity, collaboration and continuous learning. If you don't meet every requirement but believe you can make an impact, we'd still love to hear from you.
Essential
Required Qualifications
CDISC ADaM expert knowledge and compliance
ADaM dataset design, development, review, and validation
Complex derivations for ADSL, ADAE, ADLB, ADVS, ADTTE, and BDS domains
Efficacy, safety, and time-to-event analysis dataset support
Statistical programming in R and/or SAS
TLF (Tables, Listings, Figures) programming/review
Submission-ready programming activities
Traceability across Protocol, SAP, SDTM, ADaM, and TLF
Review of SAPs, protocols, mock shells, and specifications for analytical traceability
Define-XML and reviewer guides knowledge
Regulatory expectations for clinical submissions
Audit-ready documentation and review processes
Communication and stakeholder management
Preferred
Nice to Have
Agentic AI / Generative AI / AI-assisted programming workflows
Reviewing AI-generated specifications, metadata, and code
Pharmaverse knowledge
Admiral framework knowledge
Metadata-driven programming approaches
Reusable derivation frameworks / derivation catalogs
SDTM-to-ADaM automation exposure
Governance and validation frameworks for AI-enabled clinical programming
Machine-readable specifications
What you'll gain
More Than Just A Job.
We're committed to helping every team member grow professionally, personally and technically while working on meaningful projects.
Global Exposure
Collaborate with international clients and multicultural teams on enterprise programmes.
Continuous Learning
Expand your expertise through mentoring, certifications and hands-on project experience.
Career Growth
Take ownership, develop leadership skills and grow your consulting career over time.
Flexible Working
Hybrid and remote collaboration designed around trust and delivering exceptional outcomes.
People First
Join a supportive culture where collaboration, respect and long-term relationships come first.
Enterprise Projects
Work on meaningful technology initiatives for leading organisations across industries.
Apply
Apply for Associate Consultant – CDISC ADaM (Statistical Programming) SME
One page, about two minutes. We only ask for what we actually need to have a first conversation.