✨ WHY CHOOSE MEDSIR ✨

We are a Barcelona-based fastest-growing company founded by scientific experts 🔬. We are dedicated to the design and management of innovative strategic clinical trials in oncology, from study conception to the publication of study results 💊📃. Together, we create the best strategies that are both clinically relevant and scientifically meaningful 💉. We strive to improve our knowledge of this complex disease and the vast array of available treatments in a fast-innovative way 🚀.

At MEDSIR, you will have the job of your life while working together towards our shared 🌟 mission 🌟 bringing novel treatments to cancer patients worldwide. We welcome top performers that will bring new ideas, diverse perspectives, and provide you the opportunities and freedom to grow and make a real impact ❤ in patients' lives and science… all while having great fun 🎉

🤓 ABOUT THE OPPORTUNITY:

The Senior Biostatistician (Clinical trials in oncology) in our Scientific Department reports to our Data Science Manager. In this position, it is expected a proficiency level in both the full data life cycle from study design through database closure, and archival and ensure to deliver high-quality data for analysis. In addition, it is expected to have a similar proficiency level regarding statistical activities required during the design, conduct and reporting of clinical and molecular data related to research projects.

This position proposes innovation and optimization within the company and involves exposure to strategy and external and internal stakeholders contributing with the expertise from the Data Science Unit.

The position offers the opportunity to work in a cross-functional way with other members of the Scientific Department and the rest of the Company, acquiring a global view of the different aspects involved in oncological clinical research.

🎯 HOW YOU WILL CONTRIBUTE:

• Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
• Possesses in-depth knowledge of the latest clinical research trends and developments. Demonstrates a strong understanding of the global landscape and its implications for clinical research.
• Leads large projects involving complex project dynamics and ensuring alignment with strategic goals.
• Improves quality assurance activities. Consistently demonstrates a high level of attention to details and documentation management.
• Leads risk management activities/projects; monitors and reports on risk status and effectiveness of controls.
• Oversees data analysis initiatives; develops new methodologies and tools for data management.
• Participate in meetings with internal and external stakeholders in the discussion/defense of new study design contributing with data science expertise
• Participate and oversee in the development of Study Protocols by providing statistical input and data specifications.
• Design and oversee eCRF design and structure to ensure that it meets the specific requirements defined in the study protocol.
• Development and/or oversee Data Science Plan for assigned projects.
• Define or review randomization procedures and produce randomization lists.
• Development and review of Statistical Analysis Plans.
• Perform and/or supervise programming of tables, listings, figures, derived datasets, and statistical analyses according to agreed timelines and quality standards.
• Perform and/or supervise quality control of statistical output produced by other members of the department or external providers, including tables, listings, figures, derived datasets, and statistical analyses.
• Define criteria for different populations for the analysis (e.g., Safety, ITT, PP) and perform the programming for the implementation of the criteria.
• Plan and perform statistical analysis (interim and/or final) in accordance with the Study Protocol and the Statistical Analysis Plan.
• Validation of the defined statistical methods (by e g goodness-of-fit tests or model checking).
• Document and validate programs and files for analysis.
• Manage clinical data to ensure security and confidentiality.
• Produce statistical reports.
• Assist in writing/reviewing the statistical sections in the study report.
• Collaborate with other team members: clinicians, clinical researchers, operations, data management and software programmer.
• Review and provide input in interpreting analysis results to clinical study report.
• Contribute to clinical development of plan preparation.
• Assist in performing/review sample size calculations.
• Participation in international multi-stakeholder advisory boards.
• Contributes to the departmental strategy and goals, to ensure alignment with overall company strategy and goals 
• Continuous process improvement of departmental processes and procedures to ensure Data Science unit contributes to maximize efficiencies, leverage technology and incorporate innovation. 
  
  
  

💪WHAT DO WE VALUE FOR THIS OPPORTUNITY?

• A bachelor’s degree in Life Science (Biology, Biotechnology, Biomedicine, Statistics...).
• Minimum 5 years of experience in biostatistics, with a focus on oncology clinical trials, especially in Phase III studies.
  
  
  

Technical & Statistical Skills

• Design of Phase I-IV clinical trials, basket, umbrella, and adaptive trials in oncology.
• Survival analysis methods (Kaplan-Meier, Cox models, hazard ratios, landmark analysis).
• Advanced statistical methodologies:
• Application of Bayesian methods and predictive modeling in oncology.
• Statistical analysis of biomarker data and precision medicine.
• Experience with patient-reported outcomes (PROs) and composite endpoints.
  
  
  

Programming & Data Management

• Proficiency in SAS and R for advanced statistical analysis.
• Experience with CDISC standards (SDTM, ADaM) and dataset validation for regulatory submissions.
• Familiarity with clinical data management tools (EDC, IRT).
• Knowledge of Python for exploratory analysis and machine learning applications in oncology.
  
  
  

Regulatory Experience (FDA/EMA)

• Strong knowledge of ICH-GCP, FDA, and EMA regulations and oncology-specific statistical guidelines.
• Experience in preparing and defending statistical packages for regulatory submissions.
• Participation in regulatory meetings (eg: Advisory Boards).
• Preparation of responses to regulatory queries and support in FDA/EMA interactions.
• Implementation of statistical methodologies to evaluate efficacy, safety, and benefit-risk per regulatory requirements.
  
  
  

Communication & Leadership Skills

• Ability to translate complex statistical concepts for clinical, executive, and regulatory teams.
• Experience in writing and reviewing protocols, clinical study reports, and scientific publications.
• Presentation skills to defend trial designs and statistical analyses before medical, regulators and internal committees.
• Leadership in cross-functional teams (medical, regulatory, data management, and programming).
• Mentorship and supervision of junior statisticians and biostatistics teams
  
  
  

Additional Valuable Skills

• Experience with real-world evidence (RWE) and real-world data (RWD) analysis in oncology is a plus.
• Knowledge of decentralized clinical trials (DCTs) and innovative trial methodologies.
• Familiarity with medical imaging analysis and omics data in oncology.
• Ability to manage multiple projects simultaneously in a highly regulated environment with tight deadlines.
• Excellent organizational skills.
• Strong analytical and problem-solving skills.
• Commitment to working collaboratively and effectively.
• Flexibility and a willingness to respond to the needs of the work.
• Fluency in English.
  
  
  

📢 THE THINGS YOU REALLY WANNA KNOW 😉:

At MEDSIR, we believe that employees today want to evolve in collaborative, high-growth environments where they can demonstrate their abilities and thrive both professionally and personally. We are convinced that employees need to find alignment between their inner values and their company’s culture and mission to unlock their full potential. We work to create a culture of empowerment, continuous learning and growth where everyone can bring expertise, own projects and easily measure their impact 🙌

Benefits

🤓 Work with world-renowned clinicians and KOL´s on high-level publications and papers.

🚀 Fast growth, we are an early-stage company with a multidisciplinary team and many growth opportunities.

🏡 Work-life balance - 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.

🏝 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)! One subscription for the best in fitness, mindfulness, therapy, nutrition, and sleep support—all in one place.

💸 "Flexible compensation plan" to help you save taxes and increase your net salary (Cobee).

🎂 A free day on your birthday so you can truly celebrate!

🎉 Unforgettable MEDSIR events and regular get togethers.

👥 Equal employment opportunity, at MEDSIR we proudly pursue a diverse workforce and celebrate our differences.

🌇 A fantastic workplace located in 22@, Barcelona's new hub of innovation.

💻 We work with MacBook computer (Apple).

If you believe you match our values, you are unique and feel ready to make a change, we look forward to meeting you!

🧡 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.