Clinical Statistician Specialist

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
CLINICAL STATISTICIAN SPECIALIST
oversight and manage full data life cycle of our clinical trials from study design through database closure and archival and ensure to deliver high-quality data for analysis. In addition, it would be expected to develop statistical activities required during the design, conduct and reporting of clinical and molecular data related to research projects.

The position would offer 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. The position will report to the Clinical Statistician Manager.

HOW YOU WILL CONTRIBUTE:

• Participate in the development of Clinical Study Protocols by providing expert input on aspects related to data collection and management, as well as 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 DM and Biostatistics vendors, providing operational leadership and performance oversight across assigned studies (establish, monitor, and enforce vendor deliverables).
• 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/or database design and annotated CRF according to these 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.
• Strong understanding of EDC systems, data standards, and statistical workflow in clinical trials (CDISC knowledge is highly value).
• Quality control of statistical output produced by other members of the department or external parties, including tables, listings, figures, derived datasets, and statistical analyses.
• Produce statistical reports.
• Document and validate programs and files for analysis.
• Manage clinical data to ensure security and confidentiality.
• Create and review sample size calculations.
• Review and provide input in interpreting analysis results to clinical study report.
• Collaborate with other team members: clinicians, clinical researchers, clinical operations, data management and software programmer.
• 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 Analytics unit contributes to maximize efficiencies, leverage technology, and incorporate innovation.
• Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Data Analytics procedures are in line with high-standard expectations.

WHAT DO WE VALUE FOR THIS OPPORTUNITY?

• A bachelor's degree in Life Science (Biology, Biotechnology, Biomedicine...).
• MSc/PhD in Statistics or Life Sciences (containing a substantial statistical component).
• Previous experience 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.
• Knowledge of 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 a 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.

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 (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) 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.