Senior Statistician
Novo Nordisk
- Bangalore, Karnataka
- Permanent
- Full-time
- Developing statistical design while the protocol Outline and Protocol are being developed, including calculating sample size. Create statistical analysis plan. Provide statistical input to trial-related documents, including but not limited to the Clinical Study Report, mock TFL and blinding plan. Analyze trial findings and present the findings to senior management. At all times during the trial life cycle, make sure the inspection readiness documentation is updated.
- Ensure that relevant statistical documentation is made available for public disclosure such as ClinicalTrials.gov and EudraCT. Contribute statistical information to regulatory documents such as Risk Management Plan, Investigational Brochure, and DSUR/PSUR. Contribute statistical information to the creation of submission-related documents, such as ISS/ ISE. Contribute statistical input to the clinical development program's preparation and negotiation at meetings with regulatory authorities, including FDA.
- Provide statistical input to clinical trial Specification ADRG and project ADRG. Ensure that statistical analysis and output are programmed and reviewed in accordance with specifications.
- Responsibilities of an International Project Statistician include delivering results and ensuring understanding among colleagues relevant to problem-solving. Lead project teams to completion of milestones and objectives.
- Prioritize, plan, manage, and carry out Clinical Trials and submissions within the scope of the project. Mentor and develop project area successors. Fully responsible for the project's statistical methodology and deliverables.
- Minimum 4 plus years of experience working as a statistician within the pharmaceutical industry / PhD in Statistics with less experience/ Masters in statistics (or equivalent) from premier institutes with lesser experience.
- Experience with a broad range of statistical tasks. In-depth knowledge of biostatistical methods.
- Extensive experience with practical applications of biostatistical methodology.
- Broad experience with statistical software and IT and in-depth experience with at least one statistical software package.
- Good knowledge of GCP and statistical guidelines within drug development.
- Regular experience with communication of statistical issues and presentations.
- Some understanding of the pharmaceutical industry, with a focus on how to deliver on own goals.
- Solid understanding of drug development.
- Excellent written and spoken English.
- Analytical and result oriented.
- Good team player with communication and stakeholder management skills.