Padmi

Senior Statistical Analyst (Clinical Research)

BangalorePosted 2 months ago
Data Science And StatisticsSeniorFull Time; Regular
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@ Bangalore | Hyderabad | NCR Office-based for the first 3 months, with the option to move to hybrid environment based on performance. IC role, with hands-on work, 6-12yrs of experience (apply only if you have the relevant experience and expertise) What you'll do Partner with statisticians to build and implement Statistical Programming Plans and SAPs, and create ADaM data specificationsProgram and validate ADaM datasets and statistical analyses in SAS/R, aligned to CDISC standardsGenerate TLFs for CSRs, safety reports, and regulatory deliverablesBuild and maintain programming documentation, macros, utilities, and QC checksSupport audits, inspections, and regulatory submissionsHandle cross-study and integrated analyses, plus ad hoc and exploratory requestsMentor and coach new team members What you bring Master's + 6 years, or Bachelor's + 8 years, in Statistics, Computer Science, Engineering, or a related fieldStrong SAS programming (macros, data manipulation, TLF generation); R is a plusAdvanced knowledge of CDISC standards and at least one therapeutic area - Oncology, Immunology, or NeuroscienceSolid grounding in the drug development process and clinical study lifecycleComfort with protocols, SAPs, and statistical programming documentationSharp eye for detail, strong troubleshooting instincts, and clear written and verbal communicationAbility to work with statisticians, study teams, and external partners, and adapt as priorities shift @ Bangalore | Hyderabad | NCR Office-based for the first 3 months, with the option to move to hybrid environment based on performance. IC role, with hands-on work, 6-12yrs of experience (apply only if you have the relevant experience and expertise) What you'll do Partner with statisticians to build and implement Statistical Programming Plans and SAPs, and create ADaM data specificationsProgram and validate ADaM datasets and statistical analyses in SAS/R, aligned to CDISC standardsGenerate TLFs for CSRs, safety reports, and regulatory deliverablesBuild and maintain programming documentation, macros, utilities, and QC checksSupport audits, inspections, and regulatory submissionsHandle cross-study and integrated analyses, plus ad hoc and exploratory requestsMentor and coach new team members What you bring Master's + 6 years, or Bachelor's + 8 years, in Statistics, Computer Science, Engineering, or a related fieldStrong SAS programming (macros, data manipulation, TLF generation); R is a plusAdvanced knowledge of CDISC standards and at least one therapeutic area - Oncology, Immunology, or NeuroscienceSolid grounding in the drug development process and clinical study lifecycleComfort with protocols, SAPs, and statistical programming documentationSharp eye for detail, strong troubleshooting instincts, and clear written and verbal communicationAbility to work with statisticians, study teams, and external partners, and adapt as priorities shift

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