Biostatistician Sr. Specialist

Join to apply for the Biostatistician Sr. Specialist role at Zambon Zambon is a multinational pharmaceutical and chemical company focused on innovation and development to improve people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make patients’ lives better”. Zambon operates in the pharmaceutical and chemical business and is present in 20 countries with subsidiaries in three different Continents – Europe, America, and Asia – and over 2900 employees, with manufacturing units in Italy, Switzerland, France, China, and Brazil. Zambon products are commercialized in 84 countries. The company is working on treating specialties and rare diseases, such as Parkinson’s disease and Cystic Fibrosis, and is well-established in 3 therapeutic areas: respiratory, pain, and women’s care. The Role Zambon S.p.A. is seeking a "Biostatistician Sr. Specialist" to join our Global Medical Team. Main Responsibilities of the role Study Design and Protocol Development: Collaborate with clinical teams to design studies, develop protocols, and review clinical study reports (CSRs). Data Analysis and Interpretation: Plan and perform advanced statistical analyses on clinical trial data, interpret results, and provide insights to support decision‑making. Sample Size and Methodology: Determine sample size and appropriate statistical methodologies for clinical studies. Statistical Documentation: Develop and review statistical documentation, including statistical analysis plans (SAPs). SAS Programming: Create SAS programs for datasets and TLFs validation. Regulatory Submissions: Prepare and review statistical sections of regulatory submissions. Collaboration and Communication: Work closely with cross‑functional teams, including clinical, regulatory, and data management, to ensure seamless integration of statistical analyses. Quality Assurance: Ensure compliance with regulatory standards and guidelines, and maintain high‑quality documentation of statistical analyses and methodologies. Innovation and Development: Stay updated with the latest statistical techniques and contribute to the development and implementation of innovative statistical approaches. Project Management: Manage multiple projects simultaneously, ensuring timely delivery of high‑quality statistical analyses and reports. Support the management of CROs/vendors related to statistical activities. Blind Review and DMC/DSMB Support: Write and review blind review plans and reports and participate in blind review meetings. Participate in DMC/DSMB meetings and support charter preparation. Scientific Articles: Write and review statistical sections of scientific articles. What we are looking for Academic background: Master’s degree in Statistics Professional experience: At least 5 years of experience in a CRO/Pharma company as Biostatistician; experience with phase I–IV and non‑interventional studies Skills: Proficiency in English, both written and verbal; Knowledge of ICH/GCP guidelines; Advanced proficiency in SAS programming for data manipulation, statistical analysis, and reporting, and in developing and validating SAS programs for clinical trial data analysis; Proficiency in R programming for statistical analysis and data visualization; Expertise in a wide range of statistical methodologies, including survival analysis, longitudinal data analysis, and Bayesian methods; Project Management skills and ability to coordinate external resources; Demonstrated ability to work independently, take initiative, and make informed decisions; Flexibility to adapt to a fast‑paced environment and handle changing priorities effectively; Proficiency in developing innovative solutions to address challenges in clinical trial design and data analysis; Strong critical thinking skills to evaluate and interpret data accurately; Excellent verbal communication skills to clearly convey statistical concepts and results to non‑statistical stakeholders; Strong interpersonal skills to facilitate effective collaboration with cross‑functional teams; Ability to draft and review scientific manuscripts, abstracts, and presentations for publication and conferences; Ability to build and maintain professional relationships with internal and external stakeholders, including clinical teams, regulatory agencies, and industry experts. Place of Work: Bresso Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Science Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Zambon by 2x Get notified about new Biostatistician jobs in Bresso, Lombardy, Italy . #J-18808-Ljbffr