Associate Director, Statistical Programming DSP
We are looking for an Associate Director - Statistical Programming in the Drug Safety and Pharmacometrics (DSP) Group. This person provides leadership and support to Pharmacometrics project teams on all statistical programming matters according to the project strategies within and across all therapeutic focus areas (TFAs). Additionally, we expect this person to identify therapeutic specific requirements and resource requirements within the therapeutic area. They will also work with the Biostatistics group to ensure programmer needs are met regarding therapeutic analysis specifications, application and computing environment support.
The AD also works with management to identify, develop and implement departmental standards, applications, processes, and training as well as identifying resource needs based on project landmarks and deliverables. We ask that they lead all aspects of special projects/ work with clinical task force or senior management.
A typical day in the life of an AD - Statistical Programming looks like:
- Management of multiple projects across multiple TFAs following Regeneron standard data models.
- Coordination/delegation management of individual studies to all level programmers regarding programming and QC of analysis datasets and TFLs and/or integration of data across studies in support of Exposure-response, PopPK and PopPK/PD analysis and SCP (2.7.2.).
- Be responsible for the preparation, execution, reporting and documentation of project analysis programming of multiple therapeutic area using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming results.
- Build, manage and maintain the programming specification s for the analysis datasets utilizing Regeneron tools and methodologies across studies and projects.
- Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis when programming clinical data or system application deliverables.
THIS MIGHT BE THE ROLE FOR YOU IF YOU:
- Have a proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Ability to problem solve. Excellent verbal and written communication skills in a global environment.
- Detailed understanding of relational database structures and their correlation to submission ready database structures. Knowledge of CDISC data structure requirements. Experience in leading and implementing standard methodology.
In order to be considered for this role, you must have a MS or BS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with at least 8+ (10+) years of programming experience. Preferably experience will be in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including history of successful project and people management. Experience in delivering one or more submissions to regulatory authorities globally is helpful. Additionally, we would expect the ideal candidate to have:
- Advanced SAS programming skills in a clinical data environment with expertise in at least one, preferably multiple , therapeutic areas.
- Ability to identify and define departmental goals and objectives.
- Experience in project management requiring no supervision. Ability to effectively organize and manage multiple assignments with challenging timeline s.
- Detailed knowledge of regulatory requirements concerning electronic submission standards.
- SAS (Base, Stat, Macro, graph), SPLUS or R knowledge.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.