Associate Lead Statistician - India
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- Are you looking for a job where you utilize your programming skills and work with the best in the business?
- Please apply for the position as Associate lead statistician and contribute to the development of the world’s most innovative Diabetes Drugs.
- In this job you will impact the everyday life of people with diabetes.
About the department
- The Biostatistics function is growing and consists currently of 150 statisticians and statistical programmers globally in our R&D clinical development organization.
- You will be part of the growing and dynamic Bio statistics and Programming Department in Global Development – Global Service Center.
- You will be involved in the analysis and reporting of clinical trial data in the Diabetes therapeutic area, and will have opportunities to be in the lead role for trial level activities.
- You will be in a key role working with talented Statisticians and Statistical programmers and have opportunities to interact cross functionally with Data Management, Medical Writers, Medical specialists etc
- 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 give statistical input to protocol with regards to design, sample size, and analysis of endpoints in accordance with the Project Statistical Analysis Plan (SAP), ensuring inputs from the Project Statistician/International Project Statisticianreview protocol and Case Record Form (CRF)review of Trial Validation Plan (TVP)prepare SAP, if relevant, in accordance with the Project SAP prepare and participate in database lock meetingconduct statistical analyses including programming and review of statistical outputs as required and ensure preparation of other outputs according to protocol and SAPcollaborate closely with IMD, Clinical Pharmacology Scientist and other key members of study group to get input for presenting results at the results meeting, ensure review by Project Statistician/International Project Statisticiangive input to and conduct additional analyses for publications of the trial perform meta-analysis, ad-hoc analysis, exploratory analysis as required review Clinical Trial Report (CTR) and scientific publications contribute to presentation of the clinical trial results internally as well as externally ensure statistics is represented in trial publications and trial presentations according to the Vancouver Guidelines and Good Publication Practice participate in reporting of data for integrated summaries, when relevant provide input to Clinical Research Organization (CRO) statisticians or off-shoring partners and ensure review of statistical deliverables participate in study group meetings during the trial periodcarry out and/or advice on complex statistical tasks
- Responsible for providing feedback regarding trial resource situation, deliverables and any critical issues to Project Statistician/International Project Statistician provide resource estimates for statistical needs to the Project Statistician/International Project Statistician on an ongoing basis provide status on ongoing tasks to Project Statistician/International Project Statistician responsible for planning and coordination of statistical tasks in clinical trials, including contribution to statistical task prioritization within the trial Responsible to mentor less experienced Statisticians and also coordinate with them provide input and get frequent feedback on Trials handled by less experienced Statisticiansget status on ongoing tasks on trials handled by less experienced Statisticians and communicate to Project Statistician/International Project Statisticianmentor and provide input to less experienced Statisticians on statistical methods and processes promote statistical thinking, increase awareness of statistical practices and ideas within GD-GSCcapture instructive errors in the programming and validation process and ensure reporting in an issue log, ensure the errors are communicated as share lessons learned with colleagues within GD-GSC
- Responsible for sharing better practices, using project standards and Bio statistics guideline stake a lead role in the exchange of knowledge and experiences within the team of Statisticians facilitate and assist in the development of knowledge in new therapeutic areas communicate trial specific statistical improvements in the organisation
- Ensure communication to global Anchor group give input to internal courses or seminars and train in use of Bio statistics Guidelines - assist in preparing training material for internal training's contribute to the improvement of new and existing standards, take lead on global process improvement initiative(s)
- Responsible for continuous development of own skills according to Individual development plan maintain and improve statistical knowledge
- MSc. in Statistics or equivalent qualifications
- At least 5-7 years of experience working as a statistician within the pharmaceutical industry
- Experience with a broad range of statistical tasksIn-depth knowledge of biostatistical methods
- Extensive experience with practical applications of biostatistical methodologyIn-depth knowledge of drug development
- Experience with the statistical software package, decisions and actions are based on their positive impact on society, the environment and on their potential to generate a profit.
- That makes for a responsible culture with a healthy and engaging working environment.