Your role:
You will play a key role in the success of drug development, as part of a team that encourages career growth and development. As a statistical leader working in a cross-functional team, you will be responsible for developing an appropriate strategy for evidence generation to create value in a drug development program and to support evidence-based decision-making. You may independently lead very complex clinical studies or one or more oncology drug development projects in study design, data analysis and interpretation of results, authoring regulatory responses and other documents with minimal supervision. Key responsibilities will include contributing to the integrated evidence plan for a drug development program to create value for patients and support marketing authorization and reimbursement, and providing statistical leadership in the development of human research study designs while taking accountability for statistical matters in matrix leadership of other statisticians. You will ensure that statistical analyses are effectively performed and conducted with high quality and in a timely manner, and communicated to both technical and non-technical audiences. You will ensure the objective interpretation of human research study results to support informed decision-making. Furthermore, you will represent Biostatistics externally, e.g. in interactions with Health Authorities and external partnerships, and support the development of departmental standards and process improvements.
Who you are:
1. Ph.D. or MS in Statistics, Biostatistics or related discipline
2. Excellent team player (both within the project and within the function), strong communication and influencing skills, fluent in English
3. Experience working in a diverse, global working environment
4. At least 8 years of experience in the Pharmaceutical/Biotechnology industry in clinical development
5. Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies with other functions
6. Excellent knowledge of relevant guidance documents (from ICH, FDA, EMA, etc.), using them proactively to impact performance or find alternative solutions
7. Strong leadership competencies: purposeful, results-driven, innovative, collaborative, future-oriented
8. Experience in oncology preferred
Department: HC-RD-BAOL Biostatistics Oncology Late Development
Job Evaluation: AT - Expert 4 #J-18808-Ljbffr