Department- Biostatistics
Are you an expert in statistical contributions for clinical trials Do you have a passion for ensuring high-quality statistical analysis We are looking for a Statistical Specialist to join our Biostatistics department at Novo Nordisk. If you are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.
About the Department:
The Biostatistics Department was established in October 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.
The Position:
The Statistical Specialist is regarded as an expert in core statistical contributions for clinical trials and cross-trial activities within designated projects. This role entails ensuring the statistical content and quality of contributions for authority interactions, maintaining relevant standardization in statistical activities across projects, and driving various working groups that require statistical expertise.
As a Statistical Specialist at Novo Nordisk, you will have the following responsibilities:
- Expert Statistical Contributions: Provide statistical input during the design of clinical trials, ensure accurate interpretation and communication of trial results, and maintain up-to-date inspection readiness documentation throughout the trial lifecycle.
- Develop statistical content for submission documents, participate in regulatory meetings and negotiations, and represent the designated projects in interactions with regulatory authorities, including FDA Adom.
- Drive statistical strategy within clinical development programs, manage statistical responsibilities and resource allocation, and contribute to the development and implementation of new areas where Biostatistics can add value.
- Foster strong relationships and collaboration with stakeholders across the Development organization, provide mentorship and training to colleagues and act as a key resource within the project. Develop and implement statistical methodologies, challenge existing processes, and seek innovative tools to enhance efficiency, cost-effectiveness, and quality within Biostatistics.
- Develop and implement the best statistical methods and techniques. Mentor and train colleagues within the project. Drive various working groups where statistical expertise is required. Stay up to date with the latest statistical methodologies and processes
Qualifications:
- Minimum 7 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
Working at Novo Nordisk
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Deadline
30th May, 2024.
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 possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
