FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.
Key responsibilities may include, but are not limited to:
- Programming edit checks for Data Management and create tables, listings and figures for clinical study report.
- Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.
- Create or QC SDTM and QC ADaM specifications and datasets, as well as, Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf).
- Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables.
- Take initiatives and follow through to develop the Programming team. Dare to lead. Be a role model for team members.
- Bachelor’s degree in computer science, statistics or related scientific disciplines with 7+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 6+8 year of clinical programming experience.
- Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
- Good understanding of clinical drug development process
- Detail oriented
- Strong communication skills and coordination skills
- Good leadership skills