Principal Statistical Programmer (HTA) H/F

Title:

Principal Statistical Programmer (HTA) H/F

Company:

Ipsen Innovation (SAS)

Job Description:

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Knowledge, abilities & experience

Education / Certifications:

Position requires a Bachelor’s degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or Scientific Discipline, or a related field.

Experience:

7+ years of experience in the job offered or in a related occupation

Languages:

English

Key Technical Competencies Required

• Demonstrable knowledge of SAS and R programming languages;

• Demonstrable knowledge of regulatory requirements (FDA, ICH);

• Demonstrable experience in organizing NDA/s NDA regulatory submissions;

• Demonstrable experience of extracting, manipulating, summarizing, analyzing and presenting data using SAS procedures;

• Demonstrable experience of SAS/MACRO, SQL and SAS/BASE procedures;

• Demonstrable experience of SAS/GRAPH and Statistical procedures;

• Demonstrable experience of Clinical data and medical dictionaries;

• Demonstrable understanding of clinical trials - how programming deliverables fit in to the process, what types of data are collected;

• Demonstrable data structure understanding (tall and wide structures), including concept of patient;

• Demonstrable experience in developing and QC of SDTM, ADaM, Define XML and Reviewer’s Guide as per the CDISC specifications;

• Demonstrable ability to draft programming requirements from SAP;

• Demonstrable experience with study reporting; and,

• Demonstrable ability proposing and implementing solutions to technical coding issues

• Demonstrable ability to lead and manage deliveries with quality and timeliness

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.