Head of Biostatistics (m/f/x)| Muinch
In this position you will be responsible for leading the Biostatistics Group within the Biometrics departments. You will be in charge of organizing and supervising biostatistical aspects for clinical studies and regulatory submissions. Functional and disciplinary leadership, instruction, supervision, training and development of Biostatisticians. You will also be responsible for quality management including organization and appropriate quality control measures for biostatistical processes, and creation and maintenance of standard operating procedures and templates for biostatistics.
What will your tasks as ´Head of Biostatistics (m/f/x)´?
- Supervision of all statistical aspects in regulatory interactions
- Oversight of statistical activities outsourced to CRO.
- Standardisation and cross-functional collaboration by defining and developing functional standards and coordinating with other functions.
- Representation and organization of Biostatistics within the company
- Implementation of appropriate scientific/statistical methods and processes in compliance with GCP and other applicable ethical and regulatory requirements.
- Leading the Biostatistics Group within Biometrics department.
- Organisation and supervision of biostatistical aspects for clinical studies and regulatory submissions.
- Functional and disciplinary leadership, instruction, supervision, training and development of Biostatisticians.
- Scientific and organisational contribution to clinical development strategies, including clinical development plans, clinical trials, regulatory submissions and publications and further.
- Quality management including organisation and appropriate quality control measures for biostatistical processes, and creation and maintenance of standard operating procedures and templates for biostatistics.
Your requirements as ´Head of Biostatistics (m/f/x)´?
- Master degree or PhD in Statistics or mathematics with focus on statistics or equivalent
- At least 3 years of people management experience.
- 8+ years of experience as biostatistician in pharmaceutical industry or CRO
- High proficiency in mathematical statistics and knowledge of regulatory requirements for clinical development of drugs and medical devices.
- Very good communication, analytical and conceptual as well as scientific writing skills
- Business fluent English
