PrincipalStatisticalProgrammer(PK/PD)(m/w/d)

**Key Responsibilities** * Lead the development and validation of CDISC-compliant datasets (SDTM, ADaM) and Tables, Listings, and Figures (TLFs). * Design and implement PK, PK/PD, and safety ADaM datasets, ensuring compliance with industry standards and regulatory requirements. * Support Population PK (PopPK), PK/PD, and Exposure–Response (ER) analyses by developing and maintaining analysis-ready datasets. * Collaborate closely with Clinical Pharmacology, Biostatistics, and Translational Medicine teams to support early-phase decision-making. * Provide programming leadership for Phase I / First-in-Human trials, crossover designs, and PK parameter pooling strategies. * Contribute to regulatory submissions, ensuring datasets and outputs meet global health authority standards (e.g., FDA, EMA). * Develop and maintain standard programming practices, macros, and QC processes to enhance efficiency and quality. * Act as a technical lead or SME, mentoring junior programmers and guiding project delivery. * Ensure adherence to timelines, quality standards, and documentation requirements. * Support integrated analyses and pooled PK datasets across studies where required. * **Required Skills & Experience** **Technical Skills** * Expert-level proficiency in SAS programming. * Strong hands-on experience with CDISC standards (SDTM, ADaM) and TLF generation. * Proven experience in developing: * Safety datasets * PK and PK/PD ADaM datasets * Experience supporting PopPK / PK/PD / Exposure–Response workflows. * Solid understanding of early-phase clinical trial designs, including: * Phase I / First-in-Human (FIH) studies * Crossover studies * Exposure–response analysis * PK parameter pooling **Experience** * 8+ years of statistical programming experience in a pharmaceutical or CRO environment. * Demonstrated experience as a Lead Programmer or Technical Lead. * Proven track record supporting regulatory submissions. **Soft Skills** * Strong communication and stakeholder management abilitie