Senior Clinical Programmer
Swedish Orphan Biovitrum AB (publ) / Datajobb / Stockholm
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The Biostatistics, Data Management and Medical Writing department is looking for a Clinical Programmer to support projects and studies within Immunology and Haematology. The clinical programmer supports the drug development process for new substances, indications and marketing claims in the field of clinical programming.
Key Responsibilities:
Support clinical studies with programming skills.
Responsible for processing of clinical data required for analysis of clinical trials, Phase 1-4.
Develop SAS programs for preparing, processing and analysing clinical data.
Provide input to relevant clinical study documents (e.g. protocol, CRF, SAP, and report).
With deep insight in CDISC data standards and in company- and project needs, often in collaboration with CRO, review and define study data mappings and relevant programming documents.
Support regulatory response documents and other external clinical documents across multiple therapeutics area with analysis and output.
Support and drive enablement of regulatory submission documents, e.g. define.xml.
Validate work of other programmer/analysts.
Qualifications:
Master of Science (MSc) or Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.
A minimum of 5 year experience of SAS programming, preferably in the biotechnology/pharmaceutical industry and ideally with a strong understanding of clinical trial data and clinical submissions.
Experience working in a multinational environment and with external service providers (CROs).
Excellent knowledge of SAS programming including application- and macro development skills (Base SAS, Proc SQL, SAS Macro and SAS Graph).
Experience of preparing regulatory submissions in CDISC format (SDTM and ADaM ) is desired.
English, both oral and written communication.
Personal attributes:
Demonstrated ability to work in a team environment (collaborative) as well as to work independently (strong individual initiative).
Strong organisational skills, multi-tasking abilities and a highly developed respect for timelines.
Curiosity and drive to broaden skill and knowledge.
Location:
You will be based in Solna, Sweden.
Reporting to:
Mårten Vågerö, Head of Biostatistics, Data Management and Medical Writing, R&D
For more information:
If you are interested in applying for this position, please submit your CV and cover letter through our web page
www.sobi.com please contact: Mårten Vågerö,
marten.vagero@sobi.com, Head of Biostatistics, Data Management and Medical Writing
Publiceringsdatum2019-12-10Så ansöker duSista dag att ansöka är 2020-01-09
Klicka på denna länk för att göra din ansökanAdressSwedish Orphan Biovitrum AB (Publ)
Tomtebodavägen 23 A
17165 Solna
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Swedish Orphan Biovitrum AB (Publ) (org.nr 556038-9321)
Tomtebodavägen 23 A (
visa karta)
171 65 SOLNA
Arbetsplats Sobi
Jobbnummer 4995516
Observera att sista ansökningsdag har passerat.