Cytel
Senior NONMEM Programmer (with R Programming)
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JOB DESCRIPTION
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview
The position is responsible to support the PM leader or CPP leader who is the modeling lead in development and execution PK/PD Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of CPP sponsored and -supported studies for products in any phase of development. The supports are mainly focused on data related and e-submission related aspects.
Our values
- We believe in applying scientific rigor to reveal the full promise inherent in data.
- We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
- We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- We prize innovation and seek intelligent solutions using leading-edge technology.
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Responsibilities
- Prepare programming scripts (e.g. R, SAS) to generate NONMEM analysis input dataset(s) for PK and/or PD analysis, based on requests from PM leader or CPP leader who is the modeling lead.
- QC NONMEM input dataset(s) generated by another PM support. Log which QC script is used, which subjects were checked per study, what other aspects were checked within the dataset, the findings of the QC and the follow-up actions of those findings in a QC document.
- Generate e-submission package for NONMEM analysis.
- Provide guidance to new or junior members of the CPP community for the DataFlow process.
- Provide guidance to new or junior members of the CPP community for the Data Collection Tools review process.
- Interact with other departments (including but not limited to Data Management, Programming, BAN/BDS, EPOD) and external Vendors (including but not limited to PK office vendors) to communicate the needs of CPP in data collection, data formatting and data representation group discussion and cross departmental trainings if needed.
- Revise, update and create (if needed) SOPs, Job aids, templates, training materials for CPP internal processes and other cross departmental processes as needs arise.
- Improve CPP internal processes in dataset creation, dataset QC and e-submission package preparation.
- Support the needs of CPP community in Secure exchange medium set up.
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Qualifications
- Bachelor’s degree in one of the following fields: Statistics, Computer Science, Mathematics, etc.
- At least 6 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 4 years of related experience with a master’s degree or above.
- Study lead experience, preferably juggling multiple projects simultaneously preferred.
- Strong SAS data manipulation, analysis and reporting skills.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- Strong QC / validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Submissions experience utilizing define.xml and other submission documents.
- Experience supporting immunology, respiratory or oncology studies would be a plus.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
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