Statistician

6 months ago

Bengaluru, India Novo Nordisk Full time

Statistician

**Category**:Clinical Development**Location**:Bangalore, Karnataka, IN**Department-** Biostatistics
- CDS GBS- Are you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way? If so, there is a job opportunity waiting for you as our new
- ** **Lead Statistician**The Position**:

- The Statistician will be Responsible for planning, managing and execution of statistical deliverables in clinical trial and non-trial activities in the project. providing statistical input to authority required documents or meetings and Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications Additionally, the Lead Statistician is accountable for:
- Developing the trial's statistical design while the Trial Outline and Protocol are being developed, including calculating sample sizes. Create the trial's statistical analysis plan. Including but not limited to the Clinical Study Report, mock TFL, specification ADRG, and blinding plan, provide statistical input to trial-related documents. Analyse 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, such as ClinicalTrials.gov and EudraCT, is made available for public disclosure. Contribute statistical information to regulatory documents such as the Risk Management Plan, the Investigational Brochure, and the DSUR/PSUR. Contribute statistical information to the creation of submission-related documents, such as summary documentation. Contribute statistical input to the clinical development program's preparation and negotiation at meetings with regulatory authorities, including the FDA.
- Provide statistical input to the clinical trial Specification ADRG and the project ADRG. Ensure that statistical analysis and output are programmed and reviewed in accordance with specifications.
- Responsibilities of an 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.

**Qualifications**:

- Minimum 3-6 years of experience working as a statistician within the pharmaceutical industry / PhD in Statistics with lesser 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.
- 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.

**About**
***
**the Department**:
- Clinical & Data Science, Global Business Services (CDS-GBS), Biostatistics department was established in August 2010. The team has a good blend of experience and fresh perspective and comprises experienced statisticians and programmers, who form the core of the team. The main purpose & objective is to ensure high quality in preparing and conducting statistical analysis in accordance with the project milestones and provide statistical support and expertise to all clinical development activities within Novo Nordisk.**Working at Novo Nordisk**
- At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales - we’re all working to move the needle on patient care.**Contact**Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possibl

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