Principal Statistical Programmer F/M

Title:

Principal Statistical Programmer F/M

Company:

Ipsen Biopharm Ltd

Job Description:

Purpose of the position

The Principal Statistical Programmer will participate in production/QC programming, project coordination, CRO
management and oversight of vendor programming across Ipsen rare disease studies.

Main Responsabilities

To ensure the efficiency and quality of biometry deliverables; ensure that all clinical datasets meet the
standards required for regulatory submissions for all INDs and NDAs/MAAs;

• Responsible for Statistical Programming activities, including analyzing, integrating and reporting of clinical trial data in order to produce quality and timely deliverables; perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data;
• Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/ISE); create/QC of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources;
• Complete full QC validation of in-house created graphs/tables/figures and interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements;
• Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents; participate in operations meetings and address issues that may influence statistical programming and data management;
• Work with CRO statisticians, statistical programmers and review/QC their work/deliveries; understand clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation; and, execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.

Knowledge & Experience

• Proficiency in statistical programming package(s), SAS is required;
• Familiar with Global Clinical Data Interchange Standards Consortium (CDISC);
• Experience in SDTM and ADaM specification and programming;
• Experience in reporting and TFL programming.
• 5+ years’ programming experience in pharmaceutical/biotech/CRO environment in drug discovery/clinical trials / drug development

Knowledge & Experience

• R or other packages are desired

Education / Certifications

• Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline

Education / Certifications
Language

• English

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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.