Principal Statistical Programmer F/M

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