Job Description
Our client, a cutting edge scientifically driven Biotech company with strong development pipeline and multiple blockbuster products, now have a newly created role of Statistical Programming Associate Director based in their Dublin office.
The position requires demonstrated knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process.
The ideal candidate will be experienced in clinical programming data (SDTM, ADaM, clinical data checks, demographic summary table) and SAS TFL programming. Clinical Study Lead experience and project / people management skills are highly desirable.
Key duties of this role:
Assist the Head of Statistical/Clinical Programming based in the US to develop, recommend, and implement standard procedures, measures of performance, and training programs.
Responsible for multiple therapeutic areas of a statistical programming group that supports multiple drug development programs.
Serving as Principle Analyst on programs to organize and allocate resources according to multi-project requirements and deadlines.
Provide input in the selection of CROs, manage CRO programming activities for complex studies including managing CRO partner and programming activities for complex studies
Requirements for Statistical Programming Associate Director:
BS Degree in Statistics, Computer Science or equivalent. MS degree preferred.
8+ years of relevant pharmaceutical/biotech/CRO industry experience, ideally 3 years of which in a leadership role.
Expertise with SAS TFL programming, SAS software and programming standards, and accepted software development techniques.
Expert experience using industry standards such as CDASH, SDTM, and ADaM.
Demonstrated ability to manage and lead projects for Statistical Programming and freelance programmers.
Thorough understanding of the clinical trials design and reporting process and Regulatory reporting requirements (e.g. supporting NDA, BLA and EMEA filings).
Effective verbal and written communication and strong interpersonal skills.
Must work well within a dynamic, interdisciplinary,
Dynamic self-starter; agile learner; strategic and creative thinker.
Demonstrated strong problem solving and risk-mitigation skills.
For further details please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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