Full Job Description
About the department
Clinical & Data Science, Global Business Services (CDS-GBS) Biostatistics and Programming 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.
The position
As a Lead Statistician you will be responsible for conduct of statistical analyses, and reporting of data and statistical results of clinical trials using statistical methods in accordance with the project standards, as well as for planning and coordination of statistical tasks in the designated clinical trial globally, including statistical task prioritisation within the trial. You will also be providing feedback regarding trial resource situation, deliverables and any critical issues to International Project Statistician and share best practices, using project standards and Biostatistics guidelines.
You will be contributing to development incl. sample size calculation, Derived programming. You will support statistical input to design of trials, risk management plan, RMP, Statistical input to Investigator’s Brochure, IB, Development/ Periodic Safety Update Reports and DSUR/PSUR. You will be involved in presentation and negotiation of clinical development program at meetings with regulatory authorities, first submission and Post-submission activities to achieve regulatory approval to allow successful drug launch, optimal labelling and second order approvals. You will be also providing scientific support to congresses, exhibitions, advisory board meetings. You will act as an external spokesperson for statistical aspects of the project and flash statistical input to primary as well as secondary manuscript/ abstract/ poster for the clinical trial.
You will be majorly working on protocol development incl. statistical section of protocol, Case Record Form (CRF), Trial Validation Plan (TVP), data flow plan input, Building plan, CTR workflow plan, SPS and Statistical analysis plan (SAP). You will perform statistical analysis and programming of output according to specification, interpret trial results and present results for project and upper management, provide CTR Input, Public disclosure, ClinicalTrials.gov, EudraCT, Day-to-day trial execution and coordination within trial stats team, Statistical input to primary manuscript/ abstract/ poster of the clinical trial.
The Lead Statistician takes initiative and assists in solving demanding tasks and the role requires an independent, committed, detail and result oriented person. Analytical skills and a high focus on quality are important
You will be mentoring a team of Statisticians and coordinate and provide input and get frequent feedback on clinical trials handled by them.
Qualifications
You need to have the below knowledge and skills:
Phd / MSc. in Statistics or equivalent qualifications
Minimum 5-8 years of experience working as a statistician within the pharmaceutical industry OR 3+yrs experience for candidates with PhD / Masters (in Statistics) from premier institutes.
Experience with a broad range of statistical tasks
In-depth knowledge of biostatistical methods
Extensive experience with practical applications of biostatistical methodology
In-depth knowledge of drug development
Broad experience with statistical software and IT and in-depth experience with at least one statistical software package
Experience with leading / mentoring of staff
Good knowledge of GCP and statistical guidelines within drug development
Regular experience with communication of statistical issues and presentations
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. We create value by putting patients first. Working here is not just a way to make a living, but a way to make a difference.
Contact
For further queries, please contact Kavita at [email protected]
Deadline
28 Mar 2022.
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.