MidFull TimeEN
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The Biostatistician is part of the Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing Statistical tasks in assigned Study Teams, according to company policies, SOP’s and regulatory requirements.
Key Responsibilities
As a member of the Study Team, responsible for the planning, performance, report and documentation of statistical tasks during the study process.
Assist in the development of Study Protocols, CRFs and reports/manuscripts by providing statistical input
Write the statistical sections in the Study Protocol.
Review the Study Protocol.
Review the CRF to ensure that the design and structure of the CRF meets the specific statistical requirements defined in the study protocol.
Assist in performing/Review sample size calculations.
Define randomisation procedures and producing randomisation lists.
Define appropriate methods for statistical analysis.
Write the Statistical Analysis Plan.
Design the Data Presentation Plan.
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).
Perform programming of statistical analyses and study output.
Document and validate programmes 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.
Contact with clients in questions regarding statistical issues in projects.
Qualifications
A Bachelor of Science (BSc) or Master’s Degree in Biostatistics, Statistics or related discipline
Proficiency in SAS programming
Good verbal and communication skills
Ability and willingness to travel on occasion
What We Offer
We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
