Principal Statistical Programmer

Position

Job Title: Principal Statistical Programmer

Division / Function: Statistical Programming, Global Biometry

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

• 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:

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

Experience:

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

Languages:

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

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