Principal Statistical Programmer FSP
Tasks
- Build definexml files
- Create data transfer specifications
- Create data validation plans
- Create datasets
- Create listings tables and graphs
- Develop ADaM specifications
- Develop CRFs edit check specifications
- Develop R programs
- Develop SAS programs
- Develop and maintain programming standards macros
- Develop validate and maintain SAS programs
- Ensure data summaries quality and timelines
- Follow FDA regulations for trial data reporting
- Generate SDTM specifications
- Generate reviewer guide
- Implement good clinical practice
- Oversee CRO statistical programming deliverables
- Perform exploratory analyses
- Prepare DSUR
- Review SOPs and work instructions
- Support clinical study reports
- Support publications
- Support regulatory submissions
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical data standards | Clinical trial | Data Standards | Data Validation | Define.xml | Edit checks | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH | Medical terminology | R | SAS | SDTM | Trial methodology | Unix/Linux
Education
Related jobs
-
Senior Statistical Programmer FSP INR 1800K-2500KADaM | Ad Hoc Reporting | Ad-Hoc | CDISC | Clinical Trial DataFully remote | Training development and supportSenior-level Full TimeIndia R7h ago
-
Experienced I Statistical Programmer INR 1971K-3000KBiostatistics | CDISC | Clinical Practice | Clinical trials | Data ModelingEntry-level Full TimeIN022 Hyderabad, India19h ago
-
Clinical Data Science Programmer INR 800K-1820KClinical Trial Data | Clinical trial | Data Validation | Programming documentation | PythonEmployee Assistance programmes | Health and Wellbeing Programmes | Learning and development opportunities | Life assurance and disability coverage | Retirement and pension plansMid-level Full TimeIndia, Bangalore19h ago
-
Principal Data Analyst INR 2520K-3380KA/B | A/B Testing | B testing | BigQuery | DashboardingHybrid workSenior-level Full TimeIN - Bangalore, India1d ago
-
SAS Programming Consultant-Regulatory and Life Sciences Research INR 1960K-2800KClinical data | Clinical data management | Code Documentation | Data Management | Data TransformationRemote workSenior-level Full TimeBangalore, Bangalore2d ago
-
Principal Consultant - Data Science INR 3000K-5000KAnthropic | Azure | Azure OpenAI | Data Engineering | Data MiningSenior-level Full TimeIndia4d ago
-
Sr Statistical Programmer INR 1753K-2541KAnalysis Plan | Clinical data | Clinical data management | Data Management | Data ValidationCareer development | Inclusive culture | Peer recognition | Technical training | Therapeutic area trainingSenior-level Full TimeIND-Remote, India R4d ago
-
Principal Clinical Data Scientist INR 1200K-1900KClinical data | Clinical data management | Data Architecture | Data Governance | Data ManagementSenior-level Full TimeHyderabad (Office), India4d ago
-
Principal Statistical Programmer FSP INR 1500K-2500KADaM | CDISC | Clinical data | Clinical data management | Data ManagementFully remote | Support | Training and developmentSenior-level Full TimeIndia R5d ago
-
Senior Statistical Programmer FSP INR 1500K-2500KADaM | Ad Hoc Reporting | Ad-Hoc | CDISC | Clinical dataFully remote work | Training development and supportSenior-level Full TimeIndia R5d ago
-
Principal Software Development Engineer in Test INR 1500K-2500KAPI Testing | AWS CodePipeline | AWS Glue | AWS Lambda | AWS S3Senior-level Full TimeHyderabad, India5d ago
-
21 CFR | 21 CFR Part 11 | CDISC | CFR Part 11 | Clinical dataCareer development | Inclusive work environment | Mentorship and coaching | Succession planning | Training complianceSenior-level Full TimeIN022 Hyderabad, India5d ago
-
Sr. Manager - Statistical Programming, Central Services INR 2000K-2400KADaM | CDISC | Clinical Trial Transparency | Clinical trial | Define-XMLSenior-level Full TimeHyderabad, India5d ago
-
Sr Biostatistician II INR 1512K-2386KAnalysis Plan | Clinical trials | Data Management | Listing Specification | Project ManagementSenior-level Full TimeIndia - Bangalore - Bagmane Solarium …6d ago
-
Analysis Plan | Analysis dataset | Case Report Form | Clinical data | Data QualityCareer growth | Continuous learning | Global collaboration | Inclusive work cultureSenior-level Full TimeIndia7d ago
-
Principal Data Engineer (Delivery Engineering - DTC) INR 1500K-2500KAnalysis Services | Azure Data | Azure Data Factory | Azure Data Lake | Azure Data Lake StorageSenior-level Full TimeManyata Tech Park, India7d ago
-
Principal Data Engineer (Delivery Engineering - DTC) INR 1500K-2500KAnalysis Services | Azure | Azure Data | Azure Data Factory | Azure Lake StorageSenior-level Full TimeManyata Tech Park, India7d ago
-
Principal Data Engineer Ops (Engineering Ops) INR 1753K-2700KAgile | Analysis Services | Azure | Azure Analysis | Azure Analysis ServicesHybrid work model | On-call rotation supportSenior-level Full TimeManyata Tech Park, India7d ago
-
Senior Statistical Programmer INR 1632K-2209KBase SAS | Clinical Research | Data integration | Database Quality | Database Quality ControlSenior-level Full TimeHyderabad, Telangana, India7d ago
-
Principal Biostatistician INR 1290K-2078KAnalysis Plans | Budget Forecasting | Clinical Trial Design | Clinical trial | Data ListingsCareer advancement | Flexible work schedule | Generous time off | Positive work/life balanceSenior-level Full TimeHyderabad, Telangana, India7d ago
-
Principal Statistical Data Scientist INR 1200K-1900KCDISC | Data Validation | Dataset development | Documentation | PythonMentorship | Self learning and developmentSenior-level Full TimeIND - Chennai Office, India7d ago
-
Sr Statistical Programmer INR 1500K-2372KAnalysis Plan | Annotated CRFs | Clinical data | Clinical data management | Data ListingsSenior-level Full TimeIND-Remote, India R8d ago
-
Senior Statistical Programmer FSP INR 1620K-2450KADaM | CDISC | Clinical Trial Data | Clinical trial | Data ValidationCareer development | Remote work option | Support | TrainingSenior-level Full TimeIndia R10d ago
-
Statistical Programmer II INR 1294K-1848KADaM | CDASH | Clinical trial | Clinical trial reporting | Data TransformationDental insurance | Disability coverage | Employee assistance | Learning and development | Life insuranceMid-level Full TimeIndia, Bangalore11d ago
-
Principal Statistical Programmer(ADAM & TLF) INR 1290K-2091KADaM | ADaM specifications | Advanced SAS | Base SAS | Clinical SASSenior-level Full TimeIND-Hyderabad-Hybrid, India R11d ago