Biostatistician (m|f|d)*
Our client is a fast growing biotechnology company and a global market leader with numerous subsidiaries and distributors around the globe. The focus is on bringing cancer treatments and regenerative therapies to patients. The initial focus is on difficult to treat cancers using CAR-T technology whilst exploring treatments for different Therapeutic Areas.
Your Role:
Your role is to provide statistical input for clinical trials and amendments, coordinate outsourcing of statistical services in alignment and cooperation with clinical operations, data management and medical science, and ensure oversight of outsourced statistical services. You are responsible for the preparation of SAPs, SAP-updates, write or review TFLs and TFL specifications. Be accountable for selecting statistical methods for data analysis and authoring the corresponding sections of the clinical trial protocols.
Selected Key Responsibilities:
* You will perform and/or verify sample size calculations and will be accountable for selecting the statistical methods for data analysis.
* You will lead the development of statistical analysis plans and TFL shells, perform statistical analyses and validate analysis results.
* You will collaborate on the writing of clinical trial protocols, clinical trial reports, regulatory submission documents and publications.
* You will support the activities of Data Management.
* You will be managing service providers including review and approval of their deliverables in compliance with regulations and clinical good practices is also part of the role.
* Working place is Western Germany. Min 50% office based.
Your Skills and Competencies:
* You hold at least a master's degree in (bio-)statistics or a related field such as bioinformatics, or mathematics, with substantial experience in statistics.
* You have significant experience in clinical research within the pharmaceutical or biotech industry, specifically in biostatistics, and possess strong knowledge of statistical methods and proficiency in using statistical software such as SAS or similar tools.
* You demonstrate excellent organizational and analytical skills, enabling you to manage complex tasks efficiently, and take personal responsibility for your work with a structured approach.
* You have at least 5 years of experience.
* You have experience in coordinating and overseeing statistical services provided by CROs or third-party vendors, which is considered an advantage.
* You have strong verbal and written communication skills, along with a high level of documentation competence.
Please apply directly through this LinkedIn job posting
About GenSearch:
At the very heart of the Life Sciences. We are senior consultants and researchers with a past career in Pharma or Medtech organisations and a solid experience in executive search. Our team spirit, as well as a collective and cross-disciplinary approach to recruitment, ensures the best level of service to our clients. www.gensearch-consulting.com
*This job description applies equally to male, female and diverse candidates, regardless of the wording used in the text.