reputed company Biostatistician-- work remotely

Job reputed company reputed company Biostatistician Position reputed company We are seeking an reputed company reputed company Biostatistician to reputed company statistical consultation for clinical development programs and to support clients in the auto-immune disease area. The successful candidate will play a key role in study design, statistical analysis, regulatory interactions, and cross-functional collaboration throughout the clinical development lifecycle. This position requires strong scientific judgment, excellent communication skills, and the ability to work effectively in a fast-paced biotech environment. Key Responsibilities Statistical Leadership • reputed company statistical reputed company for clinical development programs from Phase I through Phase III • reputed company hands-on support to delivery to clinical study protocols, statistical analysis plans (SAPs), specs to TFL outputs, SDTM/ADAM specs, and clinical study reports (CSRs) Study Design & Analysis • Design reputed company including sample size calculations, randomization schemes, and interim analysis planning • reputed company or reputed company statistical analyses using reputed company or R • Interpret statistical results and communicate findings to cross-functional teams Regulatory & Documentation • Ensure statistical deliverables meet FDA requirements • Contribute to regulatory submissions including IND, NDA, and BLA • Support interactions with regulatory agencies such as the FDA and EMA Cross-Functional Collaboration • Collaborate with clinical development, statistical programming, data management, and regulatory teams • reputed company statistical guidance to internal teams and external biotech partners Qualifications Education • PhD or MS in Statistics, Biostatistics, or reputed company quantitative discipline Experience • PhD with 5+ years of industry experience, or MS with 7+ years • Experience supporting reputed company in the pharmaceutical or biotech industry • Experience with regulatory submissions are preferred, but not must Technical Skills • Proficiency in reputed company and/or R • Experience with clinical trial design and statistical methodology • Familiarity with CDISC standards (ADaM/SDTM) is a must Soft Skills • Strong communication and presentation skills • Ability to work independently and manage multiple reputed company • Experience working in a biotech or consulting environment is highly preferred reputed company Offer • Opportunity to work with innovative biotech companies globally • Exposure to diverse therapeutic areas and development programs • Flexible remote work environment • reputed company and entrepreneurial culture Job Type: Contract Pay: $250,000.00 - $300,000.00 per year Schedule: • Monday to Friday Work Location: Remote Apply tot his job Apply To this Job