The contractor for System and Standards completes/submits/tracks highly detailed change requests related to security and access, and advises project teams on the appropriate changes for their needs; additionally, understands hierarchical directory structures and their implications to security. The position is not statistical in nature but will support statistical programmers in the BDM department, therefore understanding of statistical programming lifecycle is desired.
In this role, a typical day might include the following:
- Analyze Indication-level security reports to determine usergroup membership requirements in line with blinding/unblinding/resourcing needs. Advise project teams on optimal usergroup membership strategy. Complete/submit/track required forms to implement optimal usergroup membership strategy.
- Analyze Indication-level security reports to determine Access Control List requirements in line with blinding/unblinding/resourcing needs. Advise project teams on optimal ACL strategy. Complete/submit/track required forms to implement optimal ACL strategy. Execute existing Linux Bash scripts to aid in this process.
- Execute various Linux Bash scripts to perform various tasks (e.g. moving files, renaming files, creating lists of directories, ...). Advise on enhancements and develop/enhance Linux Bash scripts under manager's supervision.
- Support the Global Clinical Trial Registration (gREG) process. Construct and send out by-weekly email with technical instructions for affected study teams, and track to completion their required data deliveries. Liaise between Transparency group and affected BDM study team to ensure effective communication. Spot-check deliverables and execute various Bash scripts to move and rename the deliverables according to established naming conventions. Transfer deliverables to sFTP site and inform affected parties. Ensure the cross-department tracker is kept up to date and provide feedback on its usability and possible improvements.
- Support the global Data Anonymization (gDAN) process. Liaise between Transparency group and affected BDM study team to ensure effective communication. Coordinate and track deliverables for 3 cycles per engagement: not anonymized; anonymized not sorted; anonymized sorted. Inform appropriate SME’s for QC tasks at each stage. Transfer deliverables to and from sFTP site and inform affected parties. Ensure the cross-department tracker is kept up to date and provide feedback on its usability and possible improvements.
- Support the global Data Sharing Platform (gSHARE) process. Liaise between Transparency group and affected BDM study team to ensure effective communication. Perform gDAN tasks as appropriate, then collaborate with Transparency group to ensure deliverables package is complete. Transfer to sFTP and inform affected parties. Ensure the cross-department tracker is kept up to date and provide feedback on its usability and possible improvements.
- Support the Functional Service Provider (FSP) on-boarding/off-boarding process. Complete/submit/track-controlled documents to on-board/off-board Statistical Programmers.
- Consolidate/report/track enhancement requirements
- to report generation and validation SAS utility package
- to SAS macro library for statistical analysis and data display
- of CDISC data standards, including specs, tool, process, and implementations
- for all aspects of electronic submission standards, tool, process, and implementations
- Develop collaborative work environment and be a positive role model
- Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group
- Advises management on new standards, guidelines, and recommendations
To be considered:
BS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including history of successful project and people management, and expertise in one or more therapeutic areas.
- Works independently as well as collaboratively
- Works in accordance with existing policies and standards for application to specific problems or tasks
- Extensive understanding of relational databases and experience working with complex data systems
- Role model for demonstrating collaborative teamwork
- Strong interpersonal skills that demonstrate initiative and motivation
- Strong problem-solving skills
- Excellent verbal and written communication skills in a global environment
- Experience in pharmaceutical clinical development in at least one therapeutic area (i.e. understanding of statistical concepts, techniques and clinical trial principles).
- Demonstrates ability to effectively organize and manage multiple assignments with challenging timelines and to identify areas for improvement in workflow and tool development to facilitate the process.
- Understand estimation of resource requirements
- Bash or similar scripting language, PowerShell, Python, SAS, (Base, Stat, Macro, graph) and S-Plus/R
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.