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Summary

Manager provides timely support to the project team on all programming matters according to the project strategies within a therapeutic area. As an integral part of a project team, the incumbent provides project leadership and contributes to the programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, programming specifications or user requirements/design documents using internal standards and guidelines. The incumbent is responsible for leading the programming aspect of the project, both internally or CROs, for all programming deliverables and participates in the identification and development of programming standards and macro development to facilitate the creation of statistical deliverables from a single study through to regulatory approval, product launch, and annual reports. May be asked to oversee special projects / work with clinical task force. Meets statistical adhoc requests of senior management.

Job Duties

In this role, a typical day may include:

• Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming within a therapeutic area using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Manage and coordinate programming and QC of analysis datasets and TFLs following Regeneron standard data models and/o integration of data across studies in support of CSS/CSE and esub deliverables.
• Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis when programming clinical data or system application deliverables.
• Contribute to programming development and quality control of the programming deliverables utilizing Regeneron tools and methodologies.
• Programming representative within a therapeutic area in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, programming representative for an application development to the user audience.
• Develop data models, programming standards and code, and training end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
• Mentor junior level staff in therapeutic area requirements. 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.

Job Requirements

This role may be for you if:

You can work independently, exercising judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.

You have advanced SAS programming skills, preferably in a clinical data environment.

You have experience in the analysis of at least one therapeutic area.

You have strong understanding of relational databases and experience working with sophisticated data systems.

You understand reporting systems using multiple data delivery applications.

You have been accountable for development and implementation of standardization methodology.

You are collaborative teammate with interpersonal skills that demonstrate initiative and motivation.

You have excellent verbal and written communication skills in a global environment.

You have experience in pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques and clinical trial principles within a therapeutic area) and ability to provide programming support needs for BLA and other regulatory submissions.

You have shown experience in project management with minimum supervision, including the ability to effectively coordinate and balance multiple assignments with ambitious timelines across multiple personnel.

You have experience in project start-up through submission.

You have proven success hiring, development, evaluation and support of junior staff and contractors.

You have knowledge in creation of current CDISC data structures.

To be considered, you'll need a BS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with at least 7 years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.

An advanced degree is preferred.

Experience in project and/or people management experience is necessary. SAS, (Base, Stat, Macro, graph) and S-Plus/R.

SAS Certification desirable.

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.