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Senior Statistical Programmer – II
Senior Statistical Programmer – II
Results-driven professional with 11 years of experience in clinical research, including over 5.6 years in statistical programming. Skilled in SAS (Base, SQL, Macro) and R programming for clinical data analysis, development of SDTM and ADaM datasets, and generation of TLFs per study specifications. Demonstrated expertise in clinical trial data across Phases I–III, regulatory documentation, and cross-functional collaboration. Certified in Lean, Green Belt, and Six Sigma, with strong experience in KPI management, process improvement, and client interactions.
FORMERLY AT
Sanofi
LOCATION
Bengaluru, India
AVAILABILITY
Full Time
Skills
ADaM
Aris-G
CDISC (SDTM
Data Validation
KPI Management
Macros)
Process Automation
R
R Studio
regulatory compliance
Safety Data Analytics
SAS
SAS (Base
SQL
Statistical Programming
+1 More
Work Experience
Senior Statistical Programmer – II
Sanofi
Jul 2023 – Present
Generated TLFs from ADaM datasets for Real World Evidence (RWE) studies.
Collaborated with statisticians and data managers for oncology analytics projects.
Applied advanced SAS and SQL for safety data analysis.
Mentored team members and ensured compliance with SOPs and process standards.
TECHNOLOGIES
SAS, R Studio, Aris-G,,SAS (Base, SQL, Macros), R, SQL,Statistical Programming, Data Validation, TLF Generation, Safety Data Analytics, Process Automation, KPI Management, Regulatory Compliance, CDISC – SDTM, ADaM
Senior Statistical Programmer – I
SAAMA Technologies
Feb 2023 – Jul 2023
Developed ADaM datasets and statistical outputs using Base SAS.
Coordinated programming activities with sponsors and project leads.
Ensured quality control (QC) standards and managed deliverables effectively.
TECHNOLOGIES
SAS, R Studio, Aris-G,,SAS (Base, SQL, Macros), R, SQL,Statistical Programming, Data Validation, TLF Generation, Safety Data Analytics, Process Automation, KPI Management, Regulatory Compliance, CDISC – SDTM, ADaM
Statistical Programmer
APCER Life Sciences
Feb 2020 – Feb 2023
Created and validated ADaM datasets and TLFs using SAS.
Ensured programming deliverables met regulatory and quality requirements.
Maintained comprehensive documentation and issue-tracking reports.
TECHNOLOGIES
SAS, R Studio, Aris-G,,SAS (Base, SQL, Macros), R, SQL,Statistical Programming, Data Validation, TLF Generation, Safety Data Analytics, Process Automation, KPI Management, Regulatory Compliance, CDISC – SDTM, ADaM
We handle the recruitment process, screening and shortlisting candidates.
therapeutic area, function, tools, time zone, start date.
I’m looking for:
Clinical Data Manager
Skills
Clinical Data Manager
Medical Writer
Regulatory Specialist
Biostatistician
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Interview
Arjun Mehta
we handle contracting, onboarding, and ongoing support.
Bioinformatics
Clinical Operations
Pharmacovigilance
+5 Other
Employment Contract
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Expertise
Clinical Data Manager
Medical Writer
Regulatory Specialist
Biostatistician
Data Engineer / Data Scientist
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