Job Title: Principal Biostatistician
Experience Level: 8-10 years
Company Overview: Medella Life are looking for a highly skilled and experienced Principal Biostatistician to join a dynamic team in Germany for one of our clients. This role offers the opportunity to work on cutting-edge clinical trials and contribute to the development of life-changing medical solutions.
Job Summary: As a Principal Biostatistician, you will play a crucial role in designing, analyzing, and interpreting clinical trial data. With 8-10 years of experience in the field of biostatistics, you will bring a wealth of expertise to ensure the highest quality standards in our research projects. Your proficiency in SAS programming, ADaM systems, and clinical trial methodology will be essential for the success of our trials.
Statistical Expertise: Provide leadership and expert guidance on statistical methods and analysis for clinical trials, ensuring that all statistical aspects are well-defined and executed according to regulatory standards.
Protocol Development: Collaborate with cross-functional teams to create and review clinical trial protocols, including determining sample sizes and developing statistical analysis plans.
Data Analysis: Conduct statistical analyses of clinical trial data, interpret results, and prepare clear and concise statistical reports for regulatory submissions.
SAS Programming: Use advanced SAS programming skills to create datasets, perform statistical analyses, and generate ADaM datasets in compliance with CDISC standards.
Regulatory Compliance: Ensure that all statistical activities and deliverables adhere to regulatory guidelines, such as ICH, FDA, and EMA, and participate in interactions with regulatory agencies.
Mentorship: Serve as a mentor and provide guidance to junior biostatisticians, fostering their professional development and knowledge in biostatistics.
Quality Assurance: Contribute to the development and implementation of quality control processes and continuous improvement initiatives within the biostatistics team.
Collaboration: Work closely with cross-functional teams, including clinical operations, data management, and medical affairs, to ensure the successful execution of clinical trials.
- A Master's or Ph.D. in Biostatistics or a related field.
- 8-10 years of experience in biostatistics, with a proven track record in clinical trials.
- Proficiency in SAS programming, ADaM datasets, and statistical software.
- In-depth knowledge of CDISC standards and regulatory requirements.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and in a team.
- Fluency in English and German (both written and spoken).