Associate Director Statistical Programming - Pharmacometrics

Regeneron; Village of Tarrytown (NY); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron is seeking an Associate Director Pharmacometrics Programming to provide leadership in programming for clinical studies, ensuring timely delivery of analyses per the SAP and regulatory expectations.

The role requires 4 days on-site in the Tarrytown, NY area or Warren, NJ, with expertise in SAS, CDISC standards, and cross-functional collaboration to drive data quality and submission readiness.

Qualifications

• Master's degree or higher in statistics, CS, mathematics, engineering, life sciences or related field.
• 10+ years of programming experience on clinical trial data.
• Experience in project and people management.
• SAS Certification desirable in statistics or CS.

Responsibilities

• Lead PMX programming and QC for analyses across studies.
• Develop programming specifications and data standardization.
• Coordinate with cross-functional teams for deliverables and timelines.
• Support electronic submission requirements and regulatory deliverables.
• Mentor junior staff and contribute to study design and data interpretation.

Skills

SAS programming

SAS Studio

R programming

Python

MS Excel

Education

Master's degree in Statistics, CS, Math, Eng or Life Science

Tools

Windows SAS

SAS Base/Stat/Macro/Graph

CDISC data standards

Job description

Associate Director Pharmacometrics Programming

Provides timely support to the study team on all programming matters according to the project strategies. Provides project leadership, resource planning and coordination of deliverables within project or across multiple projects. Lead programming support for processing, analyzing, and storing data from clinical studies according to a Statistical Analysis Plan, clinical pharmacology report requirement and programming specifications using internal standards and guidelines. Provides guidance in implementing and executing the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, codify programs, document program logic, and prepare programs. The incumbent is responsible for addressing administrative functions required for project management such as compilation of resource requirements and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level, and working with the department head to develop resource strategies.

This position requires 4 days onsite presence based out of Tarrytown, NY or Warren, NJ.

A Typical Day Might Include The Following

• Lead the programming and QC of analysis datasets, TFLs across multiple projects or standard tools following Regeneron standard data models or user requirements. Representation of PMX programming functions and coordination of activities with cross line functions and support planning and coordinating timelines in data exchange and deliverables. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
• Lead the integration of data across studies in support of Exposure-response, PopPK and PopPKPD analysis and 2.7.2.
• Provide programming support for all PMX deliverables in HAR request, data driven analysis, publications, and conferences.
• Plan and lead the creation and validation of electronic submission requirements (i.e. annotated CRF, data export files, define documents).
• Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.

This Role Might Be For You

• Expert SAS programming skills (SAS Base, Stat, Macro, graph) in a clinical data environment.
• Understanding of relational database structure and reporting systems utilizing multiple data delivery applications.
• Strong experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.
• Comprehensive understanding of biostatistics and pharmaceutical clinical development (e.g., safety deliverables, efficacy analysis), experienced in data handling, process and analysis and able to understand/perform Pharmacokinetics, immunogenicity, exposure response analysis in a timely manner.
• Mentor junior level staff in therapeutic area requirements. Develop collaborative work environment and be a positive role model.
• Good skills in use of relevant software, including Windows SAS, SAS Studio (Base, Stat, Macro, graph), MS-Excel, R programming and/or Python.
• Good knowledge in AI use case in statistical programming and data sciences.

To be considered for this opportunity

Must have a Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline. 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. Experience in project and people management, and expertise in one or more therapeutic areas is also preferred. SAS Certification desirable in statistics, computer science.

On‑site Requirement

Work will be performed on site. Please speak with the recruiter and hiring manager for more information about on‑site policy and expectations for this role and location.

Salary Range (annually)

$176,100.00 - $287,300.00

Equal Opportunity Statement

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.