SDTM, ADaM & TLF Programming
Salary
Not disclosed
Experience
6-10 Years
SDTM, ADaM & TLF Programming
We are seeking an experienced SDTM programmer to join our team in Bengaluru, Karnataka, India. The successful candidate will have strong SDTM programming experience and a solid understanding of CDISC standards and study requirements. The role involves developing, validating, and maintaining SAS programs for the creation, validation, and delivery of SDTM datasets.
Key Responsibilities
- Develop, validate, and maintain SAS programs for the creation, validation, and delivery of SDTM datasets in compliance with CDISC standards and study requirements.
- Perform independent programming validation and quality control to ensure the accuracy, consistency, and integrity of SDTM datasets and related deliverables.
- Provide statistical programming support to project teams, including the development of programming strategies, standards, specifications, and data conversion processes.
- Review and interpret study protocols, CRFs, data management documents, and mapping specifications to support SDTM implementation.
- Contribute to the preparation, review, and support of electronic submissions for regulatory agencies.
- Review key planning documents, including Data Review Plans and other study specifications, to ensure alignment with project objectives and programming requirements.
- Assess the impact of protocol amendments, CRF changes, and data updates on SDTM programming activities and timelines.
- Collaborate with internal stakeholders and external vendors on CDISC standards, programming conventions, specifications, data transfers, and deliverables.
- Ensure compliance with regulatory requirements, industry standards, company SOPs, and departmental best practices.
- Identify and implement opportunities to improve efficiency, quality, standardization, and consistency across SDTM programming activities.
- Independently lead and execute programming assignments with minimal supervision while providing guidance to junior programmers as needed.
- Support process improvement initiatives and contribute to the development of reusable macros, standards, and programming utilities.
Requirements
- Bachelor?s degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field.
- 7?10 years of clinical/statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
- Strong proficiency in SAS programming with extensive experience in clinical trial data processing and reporting.
- Strong hands-on experience in CDISC SDTM implementation, mapping, validation, and submission readiness.
- Thorough understanding of clinical trial data structures, relational databases, and clinical data management processes.
- Experience handling source data from various systems, including EDC and external vendor data, and transforming them into SDTM-compliant datasets.
- Strong knowledge of SDTM metadata, mapping specifications, define.xml generation, and data quality review processes.
- Experience with industry tools such as Pinnacle 21, XML, and Microsoft Office.
- Knowledge of regulatory requirements and industry standards related to clinical trial submissions.
- Good understanding of clinical trial methodologies, medical terminology, protocol design, and statistical concepts.
- Strong communication, collaboration, and problem-solving skills with the ability to work effectively in cross-functional teams.
Work Arrangements
- Full-time position based in Bengaluru, Karnataka, India.
- Remote work policy: undefined
- Office visit requirements: undefined
- Travel requirements: undefined
Additional Requirements
- Experience in ADaM dataset development.
- Experience in TLF (Tables, Listings, and Figures) programming.
- Experience supporting submission-ready deliverables and regulatory inspections.
- Knowledge of advanced reporting and visualization tools used in clinical development.
Careers at Bootminds
At Bootminds, we help global enterprises launch, scale, and optimize their Global Capability Centers (GCCs) in India with clarity, governance, and impact.
We’re not about volume — we’re about quality outcomes: strategic GCC setup, expansion, and mission
critical staffing that moves the needle.
Who We Are
Bootminds partners with global leaders to turn bold GCC ambitions into high
performance reality — from advisory and execution to building teams that deliver long
term value.
Our approach is transparent, outcome
focused, and grounded in deep GCC expertise.
Who You’ll Work With
You’ll collaborate with:
Enterprise CXOs and GCC leadership teams driving India capability strategy.
High
impact engineering, data, and functional leaders building core teams.
Cross
functional experts in consulting, operations, and talent strategy.
What Sets Us Apart
GCC
First Mindset – We live and breathe capability centre design, launch, and growth — not generic staffing.
Strategic Staffing – We staff with purpose, aligning skills and roles to real GCC outcomes.
Service
centric Culture – Whether advising leaders or partnering with candidates, we bring clarity, accountability, and respect to every interaction.
Why Join Us
Influence the blueprint of GCCs — the way global teams work, scale, and deliver from India.
Work with seasoned experts who’ve built, advised, and scaled capability centres worldwide.
Grow in a culture that values curiosity, ownership, and real impact.
If you want to help global companies build high
performing India capability hubs and love solving hard problems with clarity and grit — you’ll fit right in.