Develop and validate SDTM, ADaM, and Tables, Figures and Listings (TFLs) for Phase 1-3 studies, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
Prepare dataset specifications, define.xml files, and reviewer guides
Create patient profiles and Data Management listings
Build internal tools for standard reporting
Ensure ongoing filing of study documentation and data in Basilea's document management system
Adhere to departmental policies and procedures
Deliver high quality statistical reporting and data management services in a timely manner
Your profile
Master Degree in Biostatistics, Programming or Computational Sciences or equivalent
Minimum 10 years relevant experience in SAS programming for clinical trials, experience in anti-infectives would be an asset
Expert experience and skills in the use of SAS for development and validation of SDTM, ADaM and TFLs. Expert in SAS Stats, Graph and Macro
Ability to work both independently and collaboratively in a team environment and to positively resolve conflicts, to write clear and concise technical reports and other business correspondence
Well-organized and structured with excellent analytical skills and attention to detail
Proactiv personality with hands-on working experience
Fluent in English, spoken and written, any other language is considered beneficial
Why us?
Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success.
If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application via our careers portal.
Additional information can be found on our website www.basilea.com.
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About us
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).
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