The temporary Biostatistician provides statistical support to assigned products or programs, including under supervision response to statistical issues arising in regulatory, commercial, worldwide medical or other legal settings as required. He/She builds and maintains strong collaboration with different disciplines across the organization to identify and meet their needs for statistical support. He/She follows standard procedures within projects.
May represent Biostatistics on SMT teams as required and provides professional statistical support to clinical development teams.
Able to make decisions within a study, and at SMT level across a variety of studies with input from line or Lead Biostatistician if required.
Under supervision, able to handle requests from regulatory agencies, health authorities Interacts with team members across functional areas and multiple studies as required Ensure timeliness and high quality of Biostatistics deliverables.
Supports staff to resolve statistical or technical issues.
Thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
Broad knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas.
Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
Able to handle highly complex tasks with supervision. Must be able to deal with ambiguity.
- Knowledge of the clinical development process and the role of biostatistics
- Contribute to development of innovative/creative statistical/technical solutions to complex problems.
- Effective team player; willingness to go the extra distance to get results, meet deadlines, etc.
- Demonstrates excellent communication skills, strong organizational skills, including the ability to prioritize.
- Knowledge of current methodology research and focusing on methodology research driven by project need.
- Highly conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
- Attentive to detail. Able to write and present information effectively
- MS or PhD in Biostatistics/Statistics and equivalent
- MS in Biostatistics/Statistics with 4-6 years relevant experience
- PhD in Biostatistics/Statistics or equivalent with 2-4 years relevant work experience