Senior SAS Developer (SDTM)

Reposted 11 Hours Ago
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Budapest, HUN
Hybrid
Senior level
Pharmaceutical
The Role
Develop and validate clinical trial databases and SAS programs, produce listings/reports and patient profiles, implement SDTM/CDISC transformations, review EDC structures and validation plans, manage electronic data transfers and liaise with vendors and clients.
Summary Generated by Built In
Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

    Job Description

    We are currently looking for a knowledgeable and proactive SAS Developer to join our global Data Management team.
    Please note the official PSI CRO job title will be: Senior Database Developer.

    If you are keen to provide the full range of clinical database development and programming services, ensure high quality, accuracy, and consistency of clinical data, and be involved in something new, outstanding and challenging, this job opportunity is perfect for you!

    Responsibilities:

    • Communication point for data management and statistics on matters of database programming and deliverable database development
    • Clinical database (EDC) requirements/structure review and testing
    • Data validation plan review and programming of data validation procedures
    • Generation of clinical database listings and reports to support clinical trial data collection, tracking, review and validation
    • Programming of patient profiles
    • Participate and support the development of Study Data Tabulation Model (SDTM) (define.xml, annotated CRF, reviewer’s guide) and programming of data transformation from raw data sources into CDISC-complaint deliverable
    • Validation of clinical trial data according to SDTM specifications
    • Deliverable database transfer to clients; electronic data transfers
    • Liaison with vendors and clients regarding electronic data transfer specifications
    • Receipt and validation of electronic data transfers

    Qualifications

    • College or University degree (IT, programming, technical education)
    • Full working proficiency in English
    • Sufficient relevant technical experience
    • Experience in Clinical Data Management systems (like Medidata/Veeva) is desirable
    • Knowledge of and experience in the SAS programming language (Base SAS, SAS/Macros, SAS/ODS)
    • Knowledge of CDISC standards
    • Knowledge of and experience in SQL
    • Proficient user of standard MS Office applications and MS Access
    • Experience in a professional environment, preferably with clinical or medical data

    Only CVs in English will be considered.

    Additional Information

    We offer:

    • Excellent and flexible working conditions
    • Extensive training and friendly, collegial team
    • Competitive salary and benefits package
    • Opportunities for personal and professional growth

    If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

    Skills Required

    • College or University degree (IT, programming, technical education)
    • Full working proficiency in English
    • Sufficient relevant technical experience
    • Knowledge of and experience in the SAS programming language (Base SAS, SAS/Macros, SAS/ODS)
    • Knowledge of CDISC standards including SDTM
    • Knowledge of and experience in SQL
    • Proficient user of standard MS Office applications and MS Access
    • Experience in Clinical Data Management systems (like Medidata/Veeva)
    • Experience in a professional environment, preferably with clinical or medical data
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    The Company
    HQ: Zug
    1,939 Employees
    Year Founded: 1995

    What We Do

    PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

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