Clinical Statistician

Join TFS HealthScience a leading global midsize Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies worldwide across their entire clinical development journey. We combine the fullservice capabilities and global reach of a large CRO with the personalized approach and flexibility of a midsize firm.

Responsibilities

As part of our SRS team you will be dedicated to one sponsor in Stockholm Sweden.Your responsibilities will include:

• Clinical Development Plans: Lead statistical aspects of study design including sample size estimation and power calculations.
• Clinical Study Protocols: Provide statistical expertise in protocol reviews to ensure methodological rigor.
• Statistical Analysis Plans: Develop and approve plans for statistical analysis and contribute to PK analysis plans.
• Interim Analyses: Provide statistical input for interim data reviews and adaptive trial designs.
• CDISC/SAS Datasets: Ensure compliance with CDISC standards and contribute to the preparation of Tables Figures and Listings (TFLs).
• Clinical Study Reports: Ensure statistical integrity in final study reports including shells.
• Protocol Deviations: Evaluate protocol deviations and their statistical implications.
• Datasets and Programs Transfer: Facilitate data transfer and archiving processes with attention to regulatory standards.
• Best Practices: Stay updated with therapy area literature to apply best statistical practices.

Qualifications:

• Minimum 5 years of statistical analysis experience in clinical trials preferably in pharmaceutical or biotech industries.
• Proficiency in SAS and/or R; familiarity with CDISC standards.
• Masters or PhD in Statistics Biostatistics or related field.
• Strong understanding of clinical trial methodologies regulatory requirements and ICH guidelines.
• Excellent communication skills and ability to collaborate effectively in crossfunctional teams.
• Proven ability to manage multiple projects simultaneously and deliver highquality results under deadlines.

About Us: Founded over 27 years ago in Lund Sweden TFS HealthScience employs over 800 professionals globally delivering tailored clinical research services in 40 countries. We specialize in Dermatology Neuroscience Oncology and Ophthalmology offering flexible clinical development and strategic resourcing solutions.

Our core valuesTrust Quality Passion Flexibility and Sustainabilityguide our decisionmaking and foster a culture of innovation and excellence. Join us in making a difference towards a healthier future.