Principal Statistical Programmer

Ipsen Pharma

Les Ulis, France

Summary/purpose of the position

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

Main responsibilities/job expectations

Responsibilities will include, but are not limited to the following:

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, abilities & experience

Education/Certifications:

Bachelor’s degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or other related Scientific Discipline required.

Experience:

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

Languages:

Fluent in English.

Key Technical Competencies Required

Demonstrable knowledge of SAS programming language;
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);
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.