Description
We are seeking a Principal Statistical Programmer to join our Clinical Solutions team. As a Principal Statistical Programmer, you will play a key role in developing and validating SDTM/ADaM datasets and TLFs, preparing specifications, and generating Define.XML, ADRG, and SDRG.
Responsibilities:
- Develop and validate SDTM/ADaM datasets and TLFs
- Prepare specifications and generate Define.XML, ADRG, SDRG
- Support safety and efficacy analyses
- Contribute to e-submissions and ensure CDISC compliance
- Collaborate with cross-functional teams across studies, leading clinical study trials
Requirements:
- 8+ years of relevant clinical/SAS/statistical programming experience
- SME level review capabilities at an experienced Senior level profile
- Proven track record of leading multiple clinical trials and demonstrating proactive project management skills, lead experience of min 1+ year
- Excellent understanding of the clinical domain, CDISC standards, and experience across various therapeutic areas
- Strong communication skills, problem-solving abilities, and ability to work collaboratively in cross-functional teams, in a dynamic environment
- Therapeutic Areas: Oncology, Neurology, or any TA
- Clinical Phases: Phase-I, II, III, IV, except for dedicated Phase I exposure