Associate Director Statistical Programming - Pharmacometrics

BioSpace; 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 and expert SAS programming support for clinical studies, with responsibility for data processing, analysis, storage and submission readiness according to the SAP and programming standards.

This role requires independent design, testing, and documentation of analysis programs and close collaboration with study teams.

Qualifications

• Master's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field.
• 10+ years of programming experience in processing clinical trial data.
• Experience in project and people management; SAS certification desirable.

Responsibilities

• Lead programming and QC of analysis datasets and tables, figures, listings across projects.
• Coordinate activities with cross-functional teams and manage timelines.
• Develop and validate electronic submission components (e.g., annotated CRFs, data exports).
• Provide guidance on programming standards and data handling for regulatory submissions.
• Mentor junior programmers and support study team requirements.

Skills

SAS programming

Relational databases

CDISC data standards

Biostatistics knowledge

Mentoring

R programming

Python

MS Excel

SAS Studio

Windows SAS

Education

Master in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline

Tools

SAS Studio

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/coordinating deliverables within project or across multiple projects. Lead programming support for processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan, clinical pharmacology report requirement and programming specifications using internal standards and guidelines. Providing 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, coding programs, program documentation and preparation of programs. The incumbent is responsible for addressing administrative functions required for project management such as compilation of resource requirements and milestones, identifying/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 our Tarrytown, NY or Warren, NJ location.

A Typical Day Might Include The Following

• Lead the programming and QC of analysis datasets, TFL's 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/coordinating timelines in data exchange, 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 deliverable in HAR request, data driven analysis, publications, conference
• 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 If 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, pharmaceutical clinical development (i.e. safety deliverables, efficacy analysis), experienced in data handling, process and analysis and able to understand/perform Pharmacokinetics, immunogenicity, exposure response analysis in timely manner
• Mentor junior level staff in therapeutic area requirements. Develop collaborative work environment and be a positive role model.
• Good Skilled in use of relevant software, including Window SAS, SAS studio (Base, Stat, Macro, graph), MS-Excel, R programming and/or Python.
• Good knowledges in AI use case in statistical programming and data sciences.

To be considered for this opportunity

you must have a Master 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.

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$176,100.00 - $287,300.00