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About the role
: : Hyderabad (Hybrid / Remote) We are looking for experienced (/) and (/) to support global clinical development programs across pharmaceutical, biotechnology, and medical device clients. We are seeking highly motivated professionals with strong expertise in R programming (mandatory), SAS/SQL, CDISC standards (SDTM/ADaM), TLF programming, and clinical trial programming/statistical analysis. Experience in Oncology, Non-Oncology, Vaccines, Pharmacokinetics (PK), or Real-World Evidence (RWE) is highly desirable, along with the ability to contribute to study delivery, regulatory submissions, and cross-functional collaboration within Agile environments. Key Responsibilities: Develop, validate, and maintain SDTM, ADaM, and TLFs in accordance with CDISC standards. Perform statistical programming using R (mandatory for most roles), SAS and SQL. Lead end-to-end programming activities for clinical studies, including study start-up, delivery, submissions, and close-out. Support ISS/ISE, regulatory submissions, RTQs, and other regulatory deliverables. Serve as a Study Lead Programmer (SLP) or technical lead, coordinating programming activities across multiple studies. Program and analyse Real-World Data (RWD) from sources such as claims, EHRs, registries, and observational databases. Develop PK analysis datasets (e.g., ADPC, ADNCA, ADPP) and associated TLFs for Pharmacokinetic studies. Contribute to statistical analysis plans, protocol development, and statistical analyses for clinical and non-interventional studies. Mentor junior programmers and provide technical guidance on programming standards and best practices. Collaborate effectively with statisticians, clinical teams, pharmacologists, and cross-functional stakeholders in an Agile environment. Preferred Qualifications & Skills: Experience: 512+ years of relevant experience in Statistical Programming or Biostatistics, depending on the role and level. Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related discipline. Strong expertise in R programming (mandatory for most positions); proficiency in SAS/SQL is highly desirable. Extensive experience with CDISC standards (SDTM, ADaM) and TLF programming. Experience in Oncology is preferred for several roles; additional opportunities are available in Non-Oncology, Vaccines, and Real-World Evidence. Knowledge of ISS/ISE, regulatory submissions, and responses to regulatory queries (RTQs). Experience working with Real-World Data platforms such as MarketScan, Optum Claims, Optum EHR, IQVIA LAAD, CPRD, JMDC/MDV, Inovalon, Quest, or similar datasets. Experience leading multiple clinical studies with strong stakeholder management and communication skills. Familiarity with Agile methodologies, Jira, and modern clinical development workflows. Experience in Phase I/III clinical trials, HIV, Biomarkers, Pharmacokinetics (PK), or Pharmacoepidemiology/Outcomes Research is desirable depending on the role. Ability to work collaboratively across global teams, including alignment with US/UK time zones where required. Interested candidates may share their updated CV at: @. . #PrincipalStatisticalProgrammer #StatisticalProgramming #ClinicalProgramming #Oncology #ADaM #CDISC #TLG #ClinicalReporting #DataVisualization #Biostatistics #SASProgramming #ISS #ISE #ClinicalTrials #DrugDevelopment #PharmaJobs #LifeSciences #HyderabadJobs #HiringNow #CPVIA .