|Job title :||Scientist Biostatistician|
|Job type :||Permanent|
|Salary :||Swiss Franc120000 - Swiss Franc140000 per annum|
|Contact name :||Marco Menesello|
|Contact email :||email@example.com|
Position: Permanent, office based (1 day remote work)
Mandatory Languages: English
Salary Package: Very Competitive
The Biopharmaceutical company I am representing has a new openings for a Scientist Biostatistician within their Clinical Statistics team, across multiple therapeutic areas, to support the progression of their medicines development portfolio.
You will be playing a critical role within Research&Development at Swiss site and as part of the job, you will provide statistical input to the design, preparing statistical analysis plans, planning and conducting clinical trial analysis, reporting and interpretation of clinical studies. You will spend 10-20% of your time learning and implementing ad hoc innovative statistical approaches by following internal and external training so that together with the team, you will influence the clinical development plans, regulatory and commercial strategies, supporting the medicines development.
As part of the job, you can expect the following activities/responsibilities:
* To contribute to the definition of Clinical Development Plans, regulatory strategy and submissions
* Statistical input to clinical studies (study design, sample size calculations and statistical methodology), ensuring methods are applied consistently within a program and in line with regulatory guidelines.
* To support clinical study setup (input on CRF design, database design, specifications for randomization, IRT, ePRO and other external data).
* To interact with CROs and other external vendors to oversee statistical activities, ensuring high level of quality and timely delivery
* To drive data interpretation, to plan and conduct statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses and other analyses requested by regulatory agencies
* To collaborate in writing regulatory documents, eCTD submission modules; to attend meeting with Regulatory Authorities.
* To write/review abstracts, posters and presentations.
You'll be involved across the complete range of drug development, working in end-to-end projects, taking part in first-rate methodological research generating post-hoc and integrated analysis, ongoing evaluation of data quality and review activity.
* MSc or PhD (or equivalent) in a statistical discipline;
* Ideally, more than 6 years' experience gained within Pharmaceutical companies and/or CROs;
* Strong statistical analysis experience and ability to work independently (sample size calculation, regulatory guidelines etc.);
* Good understanding of drug development processes and strategies;
* Strong knowledge of SAS (preferably also R);
* Strong communication skills, English mandatory;
By joining the company you can expect an individual career development plan that encourages long term growth within the company, a pleasant working environment in an international and multicultural context and training panel.