Location
Secunderabad | India
Job description
The Senior Manager of Biostatistics is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. These individuals develop collaborative relationships and work effectively with the Biostatistics Lead, and other cross functional team members.
Key Responsibilities
- Collaborates in design of clinical study including methodology, data analysis & interpretation, and reporting of study results.
- Authors and/or reviews protocol synopsis, protocol, statistical analysis plans, case-report forms, clinical study reports, associated publications, and other study level specification documents under some supervision
- Performs and/or validates statistical analyses, advise ways to maximize clarity of data display
- Communicates results to cross-functional teams, provides data interpretation in study documents such as clinical study reports, and publications.
- Translates scientific questions into statistical terms and statistical concepts into layman terms.
- Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
- Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results.
- Continually enhances knowledge of drug development process, regulatory and commercial requirement
- Develops & advises team members.
- Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
- Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.
Qualifications & Experience
- Fresh PhD or MS with 2+ years experience in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
- Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
- Good interpersonal, communication, writing and organizational skills
- Ability to:
- learn regulatory requirements & clinical trial design, data analysis and interpretation,
- work successfully within cross-functional teams,
- organize multiple work assignments and establish priorities
- Experience in standard and advanced statistical methods is preferred.
- Good understanding of regulatory requirements & clinical trial design is preferred.
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