Responsibilities: Generate and validate tables, listings, and figures (TLF) based on statistical analysis plan (SAP) Work with statistician to provide statistical analysis support for publication effort Use major statistical programming language to perform data analysis for various needs Provide statistical analysis support for post approval studies Write specifications and statistical programs to generate analysis datasets and outputs data analysis tasks with minimal supervision Work with statisticians to develop statistical toolbox for advanced data modelling, tabulation, and visualization Requirements: At 3+ years' experience in medical device, pharmaceutical, biotech and/or CRO industries Strong SAS programming skill in producing various types of outputs such as TLFs and datasets Extensive statistical programming experience in producing deliverables either on scheduled or adhoc basis Experience with producing outputs submitted to the FDA and other regulatory agencies Excellent organizational skill to prioritize multiple tasks and goals to ensure timely completion Attention to detail and able to adapt to a fast-paced environment Ability to work both independently and in a cross-functional team Excellent communication skills Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance Adequate knowledge in clinical trial research methodology, ICH, GCP and regulations Experiences in medical device and cardiovascular disease is desirable, but not required Katalyst Healthcares and Life Sciences
...Description Description Were seeking a driven transaction coordinator to manage contracts throughout home selling and buying. Youll be responsible for... ...skills to make customers feel at ease. If you love working with people and thrive in a fast-paced work environment...
As a CRA II you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing:**+ Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable...
...Division is seeking motivated Lead Production Test Engineer to work at our Headquarter facility in... ...products or product components. Drives production testing development to take into... ...manufacturing environment, with a strong focus on RF systems and high-power amplifier modules....
** 10% bonus incentive plan in addition to base salary and $10,000 Sign On Bonus ** Position Overview The RN Clinical Manager works under the direction and guidance of the Branch Administrator to provide supervision of all clinical staff working with high medical...
...make America a better country. Job Description The Video Production Volunteer will contribute to ONCs mission of providing... ...public policy conversations interesting. The video production intern is responsible for the shooting, sound, and editing of the production...