Title:
Principal Statistical Programmer F/M
Company:
Ipsen Biopharm Ltd
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
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
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.