Principal Statistical Programmer

Initial Therapeutics, Inc.; New Jersey; On-site; USD 109,900 - 179,300; Full time

Job summary

Initial Therapeutics, Inc. is looking for a Principal Statistical Programmer to provide programming support for clinical studies. In this role, you will be responsible for leading programming projects, overseeing data integration, and validating submission requirements while collaborating with multidisciplinary teams.

The ideal candidate will have a Master’s Degree and at least 3 years of experience. This position offers a salary range between $109,900 and $179,300 annually.

Qualifications

• 3+ years of experience in a similar role.
• Strong understanding of programming specifications.
• Ability to collaborate with a multidisciplinary study team.

Responsibilities

• Support and lead programmer for analysis datasets and TFLs.
• Integrate data across studies for cross-study analysis.
• Support creation and validation of submission requirements.
• Collaborate with study team for analysis and reporting.
• Provide programming support for presentations and basic statistical requests.

Skills

Proficiency in SAS (Base, Statistics, Macro, Graph)

Project leadership

Programming support

Education

Master’s Degree

Job description

Principal Statistical Programmer provides timely support to the study team on all programming matters according to the project strategies.

Typical Day

As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Responsibilities include identifying requirements from the Statistical Analysis Plan, creating and executing programming specifications, guiding implementation of programming and project standards, evaluating and developing study requirements and validation plans, designing and testing program logic, coding programs, documenting programs, and preparing programs. The role also oversees projects designed to support ongoing clinical studies requests for statistical and non‑statistical analyses, meets statistical ad‑hoc requests of senior management, and maintains code, logs, and output in a regulated environment.

Key Responsibilities

• Support and/or lead programmer for programming and QC of analysis datasets, TFLs or standard tools following internal data models or user requirements. Assist in coordination of activities and communicate shifting timelines and milestones.
• Integrate data across studies to support cross‑study analysis and reporting. Create, manage and maintain programming specifications for analysis datasets using internal tools and methodologies.
• Support creation and validation of submission requirements (e.g., annotated CRFs, data export files, define documents).
• Collaborate with a multidisciplinary study team to provide timely and high‑quality support for analysis and reporting of clinical trials through regulatory approval, product launch, and annual reports. Provide department training for applications and standard tools when applicable.
• Provide programming support for simple presentations and basic statistical ad‑hoc requests, and assist with more complex data presentations.
• Participate in department working groups and contribute input toward development of tools and improvement of processes.

Required Qualifications

• Master’s Degree.
• Proficiency in SAS (Base, Statistics, Macro, Graph).
• 3+ years of experience in a similar role.

Salary Range (annually): $109,900.00 – $179,300.00

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 Traveller 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.