Principal EG Biostatistics (m/f/x)

We are looking in our European Headquarters in Munich or in our affiliates in Europe (remotely also possible) for a:

Principal EG Biostatistics (m/f/x)

The Position

The position holder will manage, with limited direction, Biostatistics study activities assigned, to support non-R&D functions, and ensure high quality deliverables are on time and within budget. The position holder will partner with internal and external stakeholders to optimize Statistical methods, processes and standards. The position holder will act as main statistical contact for the assigned study activities, in particular in cross-functional Study team(s).

Roles and Responsibilities

• Responsible for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Write SAP; Manage statistical analysis outputs with programming team; Ensure the interpretation of statistical results and provide input on reporting (CSR).

• Support Medical Affairs and HEOR/HTA strategies: Set-up additional statistical analyses required, including analyses of patient-reported outcomes (PROs) and health economic endpoints; Coordinate the statistical programmers involved in the development and execution of analyses; Provide guidance of the proper interpretation of statistical analysis results; Review or co-author the value dossier and scientific communications.

• Contribute to documents submitted to regulatory or pricing authorities.

• May participate as subject matter expert in meeting or teleconferences with health authorities.

• Responsible for providing direction and execute oversight of vendor delivery.

• May lead and/or participate in departemental initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.

• Maintains current knowledge of industry best practice in statistical methodology.

• May act as subject matter expert for statistics representing the department in cross-functional teams.

• Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards.

Personal Skills and Professional Experience:

• Master (e.g. chartered) Master’s degree or PhD (preferable) in statistics, mathematics or related fields.

• 5 to 8 years At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting.

• Experience in oncology Therapeutic Area and/or in late phase projects is an advantage.

• Strong knowledge of major statistical methods within industry standards.

• Proficiency on handling CDISC standards and statistical software such as but not limited to SAS and R.

• Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.

• Demonstrated expertise in study design, conduct and execution.

• Excellent English language skills.

• Excellent communication skills, both oral and written, in explaining in simple terms complex concepts.

• Demonstrated entrepreneurship and leadership and proactive problem solving.

• Ability and interest to work remotely with worldwide team members across cultures.