Principal Statistical Programmer (HTA) H/F

Title:
Principal Statistical Programmer (HTA) H/F

Company:
Ipsen Innovation (SAS)

Job Description:

Summary / Purpose of the Position
We are seeking a dynamic and skilled professional to join our team, focusing on exploratory programming, project coordination, CRO management, and quality control of vendor programming. This role spans therapeutic areas of Oncology and Rare Disease, ensuring the efficiency and quality of Biostatistical/Programming deliverables.

You will collaborate closely with Ipsen Health Economics and Outcomes Research (HEOR) and Global Value and Access Teams to support Health Technology Assessments.

Main Responsibilities / Job Expectations

1. Lead Statistical Programming activities, including the analysis, integration, and reporting of clinical trial data to produce high-quality, timely deliverables.
2. Perform data analysis primarily using the SAS programming language for summarizing and interpreting clinical trial data.
3. Conduct full QC validation of in-house created graphs, tables, and figures.
4. Collaborate with Statisticians, Programmers, and other clinical team members to perform ad hoc analyses and generate outputs as required.
5. Participate in operations meetings, addressing issues that may impact statistical programming and data management.
6. Work with CRO statisticians and statistical programmers, reviewing and QCing their work and deliverables.
7. Understand clinical trial design and reporting processes, including regulatory reporting requirements such as electronic data submissions and CDISC implementation.
8. Manage and execute multiple simultaneous projects and deadlines in a fast-paced environment with shifting priorities and resources.
9. Potentially manage and mentor junior or contract programmers.

Travel up to 15% may be required.

Knowledge, Abilities & Experience

Education / Certifications:
Position requires a Bachelor's degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or Scientific Discipline, or a related field.

Experience:
7+ years of experience in the job offered or in a related occupation

Languages:
English

Key Technical Competencies Required

1. Demonstrable knowledge of SAS and R programming languages.
2. Demonstrable knowledge of regulatory requirements (FDA, ICH).
3. Demonstrable experience in organizing NDA/s NDA regulatory submissions.
4. Demonstrable experience of extracting, manipulating, summarizing, analyzing and presenting data using SAS procedures.
5. Demonstrable experience of SAS/MACRO, SQL and SAS/BASE procedures.
6. Demonstrable experience of SAS/GRAPH and Statistical procedures.
7. Demonstrable experience of Clinical data and medical dictionaries.
8. Demonstrable understanding of clinical trials - how programming deliverables fit in to the process, what types of data are collected.
9. Demonstrable data structure understanding (tall and wide structures), including concept of patient.
10. Demonstrable experience in developing and QC of SDTM, ADaM, Define XML and Reviewer's Guide as per the CDISC specifications.
11. Demonstrable ability to draft programming requirements from SAP.
12. Demonstrable experience with study reporting.
13. Demonstrable ability proposing and implementing solutions to technical coding issues.
14. Demonstrable ability to lead and manage deliveries with quality and timeliness.

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.