Principal Statistical Programmer

Regeneron; New Jersey; On-site; USD 109,900 - 179,300; Full time

Job summary

Regeneron seeks a Principal Statistical Programmer to provide timely support to the study team on all programming matters according to project strategies. You will lead programming for clinical study data, design and test program logic, and ensure high-quality coding and documentation in a regulated environment.

You will work independently, oversee projects, and respond to senior management requests while aligning with the Statistical Analysis Plan and internal standards.

Qualifications

• Masters degree in a relevant field.
• Experience in statistical programming for clinical studies.
• Proficiency with SAS/Base, SAS/Stat, SAS/Macro and SAS/Graph.

Responsibilities

• Provide project leadership and programming support for processing data from clinical studies.
• Design and test program logic, code programs, document, and prepare programs.
• Oversee projects supporting ongoing clinical studies and analyses.
• Handle statistical and non‑statistical ad hoc requests from senior management.
• Maintain documentation, log files, and outputs in a regulated environment.

Skills

Statistical programming

Education

Master's Degree

Tools

SAS (Base, Stat, Macro, Graph)

Job description

A principal statistical programmer provides timely support to the study team on all programming matters according to the project strategies.

In This Role, a Typical Day Might Include

As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. The incumbent assists in 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. Oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.

This Role Might Be For You If You Have

• Support and/or lead programmer for programming and QC of analysis datasets, TFLs or standard tools following Regeneron standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and milestones.
• Integration of data across studies in support of CSS/CSE. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
• Support creation and validation of 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. If applicable, develop and provide department training for applications and standard tools developed by the department functions group.
• Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations.
• Participate in department working groups; provide input in development of tools and improvement of processes.

To be considered for this opportunity, you must have the following:

• Masters Degree
• SAS (Base, Stat, Macro, graph)
• 3+ Years experience

Salary Range (annually)

$109,900.00 - $179,300.00

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.

Equal Employment 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 (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.