Principal Statistical Programmer

Job 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.
• Therapeutic Areas: Oncology, Neurology, or any TA

Requirements

• 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(supported) therapeutic areas.
• Strong communication skills, problem-solving abilities, and ability to work collaboratively in cross-functional teams, in a dynamic environment.
• Clinical Phases: Phase-I,II,III, IV, except for dedicated Phase I exposure.
• TAs: Oncology, Neurology, Or any TA

Qualifications

• Graduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.