Principal Statistical Programmer
Il y a 7 mois
**#LI-Remote**
LI-MC1
**Summary / purpose of the position**
Position will participate in exploratory programming, project coordination, CRO management and QC of vendor programming across therapeutic areas of Oncology and Rare Disease, to ensure the efficiency and quality of Biostatistical/Programming deliverables in support of Health Technology Assessments in collaboration with Ipsen Health Economics and Outcomes Research (HEOR) and Global Value and Access Teams
**Main responsibilities / job expectations**
This role is 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; complete full QC validation of in-house created graphs/tables/figures; interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements; 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. Position may require management and tutoring of junior or contract programmers. Travel required up to 15%.
**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**:
Five+ years of experience in the job offered or in a related occupation
Languages:
English
**Key Technical Competencies Required**
- Demonstrable knowledge of SAS and R programming languages;
- 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), including concept of patient;
- 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
- Demonstrable ability to lead and manage deliveries with quality and timeliness
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