- Perform the role of the Lead Statistical Programmer
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviewers Guides to support SDTMs and ADaMs
- Develop specifications for SDTMs and ADaM datasets
- Review SAPs and TFL shells from a programming perspective for studies
- Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs
- Present and share knowledge at department meetings
- Respond to QA and client audits, and support qualification audits
- Identify processes within programming that will increase productivity, quality and efficiency
- Bachelor/Master degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- Preferred: More than 3 years' experience with proven SAS skills within a clinical trials environment.
- Solid oncology experience and CDISC knowledge.
- Submission package(eCRT) generation experience as well.
- At least one E2E Phase III onco study experience
FSP-Sr. Statistical Programmer/Principal SP - Xi'an, 中国 - Fortrea
描述
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
By joining our Clinical Trial Operations Team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds - giving you an excellent overview of best practices across the industry.
Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies.
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Education/Qualifications:
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.