Principal Statistician
2 weeks ago
Statistical Programming LeadWe are seeking an experienced Statistical Programming Lead to oversee the development and implementation of statistical programming solutions for our clinical trials. The ideal candidate will have a strong background in statistical programming, experience with CDISC standards, and excellent communication skills.About the Role:Lead the development of statistical programming deliverables, including SDTM/ADaM datasets, TLFs, and submission-ready outputs.Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory teams to ensure timely and quality deliverables.Ensure compliance with CDISC standards, regulatory guidelines, and company SOPs.Required Qualifications & Skills:Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline.7 years of hands-on statistical programming experience in clinical trials (Oncology domain preferred).Strong working knowledge of ISS or ISE programming submissions.Expertise in creating safety and efficacy analysis outputs and submission packages.Experience in edit checks development, dataset specifications, and derivation logic writing.Strong problem-solving, analytical, and documentation skills.Ability to work independently along with effective stakeholder communication.What We Offer:A dynamic and supportive team environment, opportunities for professional growth and development, and a competitive compensation package.