Sr Stat/ Pr Stat Programmer (PKPD Programming) in India at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr Stat/Pr Stat Programmer (PKPD Programming) in India.

This role sits at the intersection of clinical research, biostatistics, and advanced statistical programming, supporting the development of life-changing therapies across global clinical trials. You will play a critical role in transforming complex pharmacokinetic and pharmacodynamic data into high-quality analysis-ready datasets and statistical outputs that directly support regulatory submissions and clinical decision-making. Working within a highly collaborative, science-driven environment, you will partner closely with statisticians, clinical pharmacologists, and study teams to ensure accuracy, consistency, and scientific integrity of all deliverables. The role requires strong technical expertise in SAS and R, as well as deep understanding of PK/PD workflows and CDISC standards. You will also contribute as a technical lead, guiding programming activities and ensuring best practices across studies. This is a high-impact position where your work directly contributes to accelerating drug development and improving patient outcomes worldwide.

• Develop and validate statistical programming outputs using SAS and R, including tables, listings, figures, and derived datasets in alignment with statistical analysis plans.
• Design and implement PK/PD analysis datasets such as ADPC, ADPP, and ADNCA, ensuring compliance with CDISC standards and study requirements.
• Generate and validate NCA and NONMEM datasets, supporting pharmacokinetic and pharmacodynamic analyses.
• Ensure programming outputs meet quality standards through validation, peer review, and resolution of discrepancies with cross-functional teams.
• Serve as lead statistical programmer, coordinating programming activities and ensuring timely delivery of study outputs across multiple projects.
• Collaborate with biostatisticians, clinical pharmacologists, and study teams to translate analytical requirements into efficient programming solutions.
• Maintain complete, audit-ready documentation and ensure adherence to SOPs, regulatory guidelines, and quality processes.
• Participate in sponsor interactions, study meetings, and bid defenses as the statistical programming representative when required.
• Mentor junior programmers and contribute to internal training, knowledge sharing, and process improvement initiatives.

• Bachelor’s degree in Mathematics, Statistics, Computer Science, or a related field.
• 5+ years of experience in clinical statistical programming or pharmaceutical/biostatistics environments.
• Strong expertise in SAS and intermediate to advanced proficiency in R.
• Solid knowledge of PK/PD workflows, clinical trial study designs, and pharmacokinetic analysis principles.
• Strong understanding of CDISC standards and regulatory requirements in clinical programming.
• Experience developing PK analysis datasets (ADPC, ADPP, ADNCA) and generating TLFs for clinical reporting.
• Hands-on experience with NONMEM and NCA datasets.
• Strong analytical, problem-solving, and debugging skills in complex clinical data environments.
• Ability to manage multiple projects, prioritize tasks, and meet strict timelines.
• Excellent communication skills with the ability to explain complex analytical concepts clearly.
• Experience acting as a technical lead or mentoring junior programmers is highly valued.

• Competitive compensation package aligned with industry standards.
• Flexible remote work arrangement.
• Career development and progression opportunities in global clinical research programs.
• Access to structured learning programs, technical training, and knowledge-sharing initiatives.
• Participation in large-scale global clinical studies with high scientific and regulatory impact.
• Collaborative, inclusive, and science-driven work environment.
• Exposure to advanced tools, methodologies, and leading-edge drug development programs.