[Hiring] Senior NONMEM Programmer @Cytel

Role 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.

The position is responsible for supporting the PM leader or CPP leader who is the modeling lead in development and execution of 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.

Responsibilities

• Prepare programming scripts (e.g. R, SAS) to generate NONMEM analysis input dataset(s) for PK and/or PD analysis.
• Modify the variable definition file during dataset generation.
• QC NONMEM input dataset(s) generated by another PM support.
• 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 and external vendors to communicate the needs of CPP.
• Revise, update and create SOPs, Job aids, templates, training materials for CPP internal processes.
• 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.

Qualifications

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field.
• At least 6 years of SAS programming experience 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.
• 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.