Biostatistician - Director Level, Global Medical Affairs - Switzerland
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- Our company employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do.
- Our company is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines.
- Our company focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases.
- Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
- Our company is looking for a strong statistician to fill a full-time permanent position of Senior Scientific Fellow within Global Statistics, to support the gastroenterology (GI) area of Global Medical Affairs, with a focus on Specialty GI (e.g., Inflammatory Bowel Disease).
- The Senior Scientific Fellow for GMA Statistics is a recognized technical expert and thought-leader who provides broad statistical leadership for Global Medical Affairs (GMA) support in one large TA.
- He/she serves as a strategic partner for the GMA TA head and acquires statistical resources to support all GMA activities in the TA.
- He/She also identifies and develops innovative statistical methodologies and ensures that the Statistics Department is strategically and tactically positioned to meet current and future business needs and regulatory requirements.
- Serve as a thinking and planning partner for GMA TA head. Obtain and manage flexible statistics resources to support all GMA activities
- Provide statistical expertise for GMA activities including publications, GMA interventional trial designs, real world data analysis, etc.
- Ensures that technical and scientific standards within Statistics meet current industry trends.
- Advises Statistics leadership and project teams on innovative statistical methodology to increase clinical trial efficiency and soundness of publications.
- Monitors and influences advances in statistical and clinical trial methodology and serves as internal expert for the Global Statistics Organization with high degree of accountability.
- Oversees and monitors strategic initiatives aimed at improving decision-making and quality of deliverables.
- Identifies and collaborates with external statistical experts for issues related to design and analysis methodology for GMA projects.
- Critically reviews technical and scientific reports from external sources and provides input to the project team as appropriate.
- Conduct original research on relevant statistical topics focusing on current industry trends and coordinates learning/training opportunities within Statistics and for other functional areas.
- PhD in statistics or biostatistics with minimum of 13 years of relevant experience or MS in statistics or biostatistics with minimum of 15 years of relevant experience.
- Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures
- Active in statistical/pharmaceutical professional organizations at regional or national level.
- Proven original research capability with a track record of statistical publications
- Proven collaborative research capability with a track record of medical/public health publications
- Ability to convey statistical argument and concept to influence audience at all levels and with diverse disciplines
- Advanced knowledge of the pharmaceutical industry.
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
- Ability to engage in statistical discussions with Regulatory Authorities.
- Excellent oral and written communications skills.