Principal Statistical Programmer FSP
Tasks
- Create maintain document validate programming standards macros
- Develop CRFs, edit check specifications, data validation plans
- Develop SAS programs for datasets, listings, tables, graphs
- Develop validate maintain SAS and R programs for clinical development
- Follow FDA regulations good clinical practice electronic submissions
- Generate SDTM ADaM specifications datasets reviewer guide define xml
- Oversee CRO statistical programming deliverables
- Prepare clinical study reports regulatory submissions publications DSUR exploratory analyses
- Review author SOPs work instructions for statistical programming practices
- Review author data transfer specifications for external vendors
Perks/Benefits
Skills/Tech-stack
ADaM | Biostatistics Programming | CDISC | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical trial | Define-XML | FDA | Git | Good Clinical Practice | ICH | Markdown | Medical terminology | Pharmacokinetics | R | SAS | SDTM | Trial methodology | Unix/Linux
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
Related jobs
-
Principal Offer Optimization and Data Science INR 1890K-2700KC++ | Dynamic Pricing | Experimentation | Google BigQuery | JavaOnsite customer support | Travel 30 to 50 percentSenior-level Full TimeIndia - Bangalore-Navigator Bldg22h ago
-
Associate Clinical SAS Programmer INR 960K-1500KCase Report Form | Clinical Database | DBD | Data Capture | Edit checksMid-level Full TimeIN - Bangalore, India22h ago
-
Principal Data Modeling INR 2400K-5000KCI/CD | Clustering | DBT | Data Contracts | Data GovernanceFlexible work environment | Internal mobility | Volunteering support | Well-being | Work-life balanceSenior-level Full TimeKA Bangalore, India1d ago
-
Principal Data Engineer- Hyderabad (Hybrid) INR 3000K-4000KAPI Architecture | Apache Spark | Artificial Intelligence | Automation | AzureCareer development | Inclusive culture | Peer recognition | Supportive line management | Technical trainingSenior-level Full TimeIND-Hyderabad, India R1d ago
-
Principal Associate, Data Science INR 1500K-2000KBacktesting | Classification | Cloud Computing | Clustering | Confusion matrixSenior-level Full TimeBangalore, In, India1d ago
-
Statistical Programmer II INR 2535K-4200KADaM | CDISC | Pinnacle 21 | Pinnacle 21 Validator | PythonHybrid work schedule | Relocation support within countrySenior-level Full TimeIndia - Bangalore1d ago
-
Senior Clinical SAS Programmer INR 2486K-3500KClinical data | Data Capture | Data Management | Data Validation | Data cleaningSenior-level Full TimeIN - Bangalore, India1d ago
-
Senior Principal Clinical Programmer (DM SAS) INR 1303K-2270KAutomation | Cause analysis | Clinical programming | Cloud Computing | Code optimizationSenior-level Full TimeIND-Hyderabad-Hybrid, India R1d ago
-
Principal Biostatistician(Clinical Pharmacology) INR 2493K-4072KBiostatistics | Clinical trial | Clinical trial analysis | R | Regulatory ComplianceCareer development | Inclusive work culture | Technical training | Total rewards programSenior-level Full TimeIND-Remote, India R1d ago
-
Mid-level Full TimeIND-Pune-Hybrid, India R1d ago
-
Statistical Programmer II INR 2535K-4200KADaM | CDISC | CDISC standards | Clinical drug development | Drug developmentHybrid work option | Relocation supportSenior-level Full TimeIndia - Bangalore1d ago
-
21 CFR | 21 CFR Part 11 | Analysis standards | CDISC | CFR Part 11Senior-level Full TimeIN022 Hyderabad, India4d ago
-
CDISC | Clinical Practice | Clinical trials | Data Modeling | Data PrivacyMid-level Full TimeIN022 Hyderabad, India4d ago
-
Senior Principal Statistical Programmer INR 2500K-4000KAI machine learning | CDISC | Clinical trials | Data Analysis | Data StructuresSenior-level Full TimeHyderabad (Office), India4d ago
-
Principal Statistical Programmer INR 2000K-3500KAI/ML | CDISC | Clinical data | Clinical data management | Clinical trialsSenior-level Full TimeHyderabad (Office), India4d ago
-
Senior Principal Data Scientist - GenAI.ML / AgenticAI INR 2500K-4500KAgent systems | Agentic AI | Agile | Azure | CI/CDEmployee Assistance Program (EAP) | Flexible working environment | LinkedIn Learning | Volunteer time offSenior-level Full TimePune, MH, India5d ago
-
Principal AI and Machine Learning Engineer INR 2500K-4590KAdversarial Networks | Agile | Artificial Intelligence | C++ | CalculusCareer Development Programs | Health and wellbeing benefits | Hybrid work | Inclusion and Diversity supportSenior-level Full TimeBengaluru, Karnātaka, India5d ago
-
Principal Offer Optimization Delivery INR 2000K-3900KAirline Offer Management | C++ | Competitive benchmarking | Data Validation | Database ConceptsCustomer-facing work | Hybrid work | Travel opportunitiesSenior-level Full TimeIndia - Bangalore-Navigator Bldg5d ago
-
Principal AI and Machine Learning Engineer INR 2500K-4590KAdversarial Networks | Agile | C++ | Calculus | Cloud ComputingHealth and wellbeing benefits | Hybrid work schedule | Professional development programsSenior-level Full TimeBengaluru, Karnātaka, India5d ago
-
Principal AI and Machine Learning Engineer INR 2500K-4590KAdversarial Networks | Agile Development | C++ | Cloud services | Computer VisionCareer Development Programs | Health and wellbeing benefits | Hybrid work scheduleSenior-level Full TimeBengaluru, Karnātaka, India5d ago
-
Principal Data Scientist- Hyderabad (Hydrid) INR 3000K-4000KAzure | Azure Databricks | Causal Inference | Causal analysis | Data GovernanceCareer developmentSenior-level Full TimeIND-Hyderabad, India6d ago
-
Principal Engineer - (Embedded Platform Software, RTOS) INR 1500K-2372KARM | ARM architecture | Analyzers | Board Bring-up | Board SupportCar lease programme | Contingency leave | Employee scholar programme | Fuel and maintenance allowance | Group health insuranceSenior-level Full TimeIN-KA-BENGALURU-NORTHGATE ~ Sy No 2/2 Venkatala …6d ago
-
Principal Statistical Programmer INR 3000K-4000K21 CFR | 21 CFR Part 11 | ADaM | Analysis Data Model | Analysis PlanHybrid workSenior-level Full TimeIN025 Embassy Manyata Business Park, India6d ago
-
Blinding | Clinical trials | IRT | Macro | Process ImprovementSenior-level Full TimeIndia - Hyderabad6d ago
-
Lead Statistical Programmer INR 2486K-3307KCDISC | Data specifications | Deliverable tracking | GCP | GxPRelocation assistanceSenior-level Full TimeBangalore - AGS, India6d ago