Clinical Statistician Specialist

Clinical Statistician Specialist role at MEDSIR Overview MEDSIR is a Barcelona-based company dedicated to the design and management of innovative strategic clinical trials in oncology from study conception to publication of results. The mission is to bring novel treatments to cancer patients worldwide while fostering a collaborative and high-growth environment. Responsibilities Participate in the development of Clinical Study Protocols by providing expert input on data collection and management, and statistical analysis. Oversee all data management activities including CRF design, database build and validation, data cleaning, query management, coding, SAE reconciliation, and database lock. Oversee statistical deliverables such as statistical analysis plans, mock shells, programming specifications, TLF generation, data transfers, and submission‑ready outputs. Serve as primary point of contact for all data management and biostatistics vendors, providing operational leadership and performance oversight across assigned studies. Identify and implement solutions to project data management requirements, including proactive prevention strategies based on metrics and forecasts. Contribute to the development of the clinical data model and database design, and annotated CRF according to specifications. Review data acquisition conventions and data review guidelines/diagnostic specifications consistent with the clinical data model, statistical analysis plans, and CRF completion/monitoring conventions. Generate and review sample size calculations. Maintain strong understanding of EDC systems, data standards, and statistical workflow in clinical trials (CDISC knowledge is highly valuable). Perform quality control of statistical output produced by other department members or external parties, including tables, listings, figures, derived datasets, and statistical analyses. Produce statistical reports and document and validate programs and files for analysis. Manage clinical data to ensure security and confidentiality. Collaborate with other team members: clinicians, clinical researchers, clinical operations, data management and software programmers. Contribute to departmental strategy and goals to ensure alignment with overall company strategy. Continuously improve departmental processes and procedures to maximize efficiencies, leverage technology, and incorporate innovation. Maintain working knowledge of regulatory requirements/guidance and industry leading best practices to ensure Data Analytics procedures align with high‑standard expectations. Qualifications A bachelor’s degree in Life Science (Biology, Biotechnology, Biomedicine, etc.). MSc/PhD in Statistics or Life Sciences with substantial statistical component. Previous experience of at least 3 years in oncology. Advanced knowledge of study designs and statistical analysis conventions in oncology. Knowledge and expertise in working with large, complex data sets from clinical trials or real‑world data is highly valued. Proficiency in analysis of health‑related data. Experience with one or more relevant analysis packages: R, Python, SAS. Detail oriented with the ability to multi‑task efficiently. Excellent organizational skills. Strong analytical and problem‑solving skills. Commitment to working collaboratively and effectively. Flexibility and willingness to respond to the needs of the work. Fluency in English. Proven competence in managing multiple projects independently through full data management study life cycle. Benefits Work with world‑renowned clinicians and key opinion leaders on high‑level publications and papers. Fast growth opportunity as an early‑stage multidisciplinary team. Hybrid working model and flexible hours focusing on performance rather than office hours. Unlimited access to GoodHabitz courses and regular workshops (external & internal) to continue your development. Opportunities to participate in scientific conferences & events at national and international level. Private health insurance (AXA). Work‑from‑abroad policy depending on position and local legislation. A young & international team with a company culture focused on development. Positive, dynamic, and passionate work environment. Elevate your wellness with Wellhub (formerly GymPass) subscription covering fitness, mindfulness, therapy, nutrition, and sleep support. Flexible compensation plan to help you save taxes and increase your net salary (Cobee). A free day on your birthday to truly celebrate. Unforgettable MEDSIR events and regular get‑togethers. Equal employment opportunity: MEDSIR proudly pursues a diverse workforce and celebrates our differences. Located in 22@, Barcelona's new hub of innovation. MACBook computer (Apple) provided. Equal Employment Opportunity We are committed to fostering a diverse and inclusive workplace, where all individuals are treated with respect and equality, regardless of race, gender, age, religion, disability, or any other characteristic. We believe in providing equal opportunities for all and do not tolerate discrimination in any form. #J-18808-Ljbffr