Key Responsibilities
1. Lead the development and validation of CDISC-compliant datasets (SDTM, ADaM) and Tables, Listings, and Figures (TLFs).
2. Design and implement PK, PK/PD, and safety ADaM datasets, ensuring compliance with industry standards and regulatory requirements.
3. Support Population PK (PopPK), PK/PD, and Exposure–Response (ER) analyses by developing and maintaining analysis-ready datasets.
4. Collaborate closely with Clinical Pharmacology, Biostatistics, and Translational Medicine teams to support early-phase decision-making.
5. Provide programming leadership for Phase I / First-in-Human trials, crossover designs, and PK parameter pooling strategies.
6. Contribute to regulatory submissions, ensuring datasets and outputs meet global health authority standards (e.g., FDA, EMA).
7. Develop and maintain standard programming practices, macros, and QC processes to enhance efficiency and quality.
8. Act as a technical lead or SME, mentoring junior programmers and guiding project delivery.
9. Ensure adherence to timelines, quality standards, and documentation requirements.
10. Support integrated analyses and pooled PK datasets across studies where required.
Required Skills & Experience
Technical Skills
11. Expert-level proficiency in SAS programming.
12. Strong hands-on experience with CDISC standards (SDTM, ADaM) and TLF generation.
13. Proven experience in developing:Safety datasetsPK and PK/PD ADaM datasets
14. Experience supporting PopPK / PK/PD / Exposure–Response workflows.
15. Solid understanding of early-phase clinical trial designs, including:Phase I / First-in-Human (FIH) studiesCrossover studiesExposure–response analysisPK parameter pooling
Experience
16. 8+ years of statistical programming experience in a pharmaceutical or CRO environment.
17. Demonstrated experience as a Lead Programmer or Technical Lead.
18. Proven track record supporting regulatory submissions.
Soft Skills
19. Strong communication and stakeholder management abilities.
20. Ability to work independently and manage multiple priorities effectively.
21. Highly detail-oriented with a strong commitment to quality and timelines.
Preferred Qualifications
22. Experience supporting Translational Medicine or Clinical Pharmacology functions.
23. Familiarity with exploratory analyses and early-phase clinical decision-making.
24. Experience with integrated summaries and pooled PK analyses across studies.
25. Exposure to cross-functional collaboration in drug development environments.
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