This is an outstanding opportunity with a Pharmaceutical leader in the industry!
Full-time role with very competitive total compensation package (base salary+15-20% bonus+LTI incentives)
This position supports the activities/projects in Oncology Business Group including clinical studies design and analysis, publications as well as regulatory interactions.
1. Independently reviews whole protocols and interfaces with clinicians and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration etc. for multiple studies
2. Develops and/ or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. Support clinical trial related publications
3. Independently provides statistical and validation support for analysis datasets, statistical tables, figures and listings. Performs and validates statistical analysis. Independently reviews CSRs and performs data interpretation
4. Work with the internal / CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs
5. Function as lead statistician in global registration trials and manage all related statistical activities
6. Leads preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses
7. Manage contract statisticians in the group. Provide mentoring and oversee work assigned
• Minimum of a Master’s degree in Biostatistics (PhD highly preferred) or related discipline with at least 10+ years of relevant experience in the pharmaceutical industry/CRO environment
• Management experience is preferred
• Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process
• Experience with CRO oversight and FDA submission preferred.
• Excellent technical writing and verbal communication skills.
• Strong teamwork ability/commitment and individual initiative.
• Strong organizational skills with ability to effectively manage multiple studies