Padmi

Senior Statistical Analyst (Clinical Research) (Bengaluru)

BangalorePosted 1 month 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 workplace 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 specifications - Program and validate ADaM datasets and statistical analyses in SAS/R, aligned to CDISC standards - Generate TLFs for CSRs, safety reports, and regulatory deliverables - Build and maintain programming documentation, macros, utilities, and QC checks - Support audits, inspections, and regulatory submissions - Handle cross-study and integrated analyses, plus ad hoc and exploratory requests - Mentor 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 field - Robust SAS programming (macros, data manipulation, TLF generation); R is a plus - Advanced knowledge of CDISC standards and at least one therapeutic area - Oncology, Immunology, or Neuroscience - Solid grounding in the drug development process and clinical study lifecycle - Comfort with protocols, SAPs, and statistical programming documentation - Sharp eye for detail, strong troubleshooting instincts, and clear written and verbal communication - Ability 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 workplace 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 specifications - Program and validate ADaM datasets and statistical analyses in SAS/R, aligned to CDISC standards - Generate TLFs for CSRs, safety reports, and regulatory deliverables - Build and maintain programming documentation, macros, utilities, and QC checks - Support audits, inspections, and regulatory submissions - Handle cross-study and integrated analyses, plus ad hoc and exploratory requests - Mentor 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 field - Robust SAS programming (macros, data manipulation, TLF generation); R is a plus - Advanced knowledge of CDISC standards and at least one therapeutic area - Oncology, Immunology, or Neuroscience - Solid grounding in the drug development process and clinical study lifecycle - Comfort with protocols, SAPs, and statistical programming documentation - Sharp eye for detail, strong troubleshooting instincts, and clear written and verbal communication - Ability to work with statisticians, study teams, and external partners, and adapt as priorities shift

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