Principal Statistical Programmer

Title:

Principal Statistical Programmer

Company:

Ipsen Bioscience, Inc.

Job Description:

Principal Statistical Programmer

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.

The annual base salary range for this position is $112,500-$165,000.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation