Principal Stat Programmer
On-siteBengaluru, Karnataka, India
Bengaluru, Karnataka, IndiaOn-siteFull TimeSenior LevelSmall
Full TimeSenior LevelSmall
Job Summary
Develop efficacy ADaM and TFL deliverables for Oncology and Immunology studies, focusing on ADTTE-based analyses for PFS, OS, DOR, BOR, and ORR. Create statistical outputs and visualizations including Kaplan–Meier plots and forest plots using SAS procedures such as PROC LIFETEST, PROC PHREG, and PROC MIXED. Support Phase II and Phase III clinical studies while managing PK/PD datasets and adhering to regulatory and quality standards. This role requires 10+ years of hands-on experience in ADaM and TFL programming with strong R expertise. Apply via the Lifelancer platform to access the application page.
Required Qualifications
- 10+ years of hands-on experience in ADaM and TFL programming
- Strong exposure to R programming
- Extensive experience in Efficacy ADaMs and TFL development
- Strong exposure within Oncology and Immunology studies
- Strong expertise in Oncology efficacy endpoints
- ADTTE-based analyses such as PFS, OS, DOR, BOR, and ORR
- Proven experience supporting Phase II and Phase III clinical studies
- In-depth knowledge of Oncology efficacy ADaM datasets
- ADTR, ADRS, ADQS, ADTTE
- Experience with Non-Oncology efficacy datasets
- ADEFF, ADQS
- Working knowledge of PK/PD datasets used for pharmacokinetic and pharmacodynamic analyses
- ADPD, ADPC, ADPK, ADPP
- Strong experience creating Oncology statistical outputs and visualizations
- Kaplan–Meier (KM) plots
- Forest plots
- Hands-on experience with key SAS statistical procedures
- PROC LIFETEST
- PROC PHREG
- PROC MIXED
- Ability to work independently on complex programming deliverables while adhering to regulatory and quality standards
- Zero tolerance policy for candidate fraud
- All information and credentials submitted in your application must be truthful and complete
Desired Qualifications
- Proven experience supporting Phase II and Phase III clinical studies (preferred)
- Proven experience supporting Phase II and Phase III clinical studies
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