Senior Manager, Statistical Programming

BioSpace; Cambridge (MA); On-site; USD 150,500 - 245,500; Full time

Job summary

Regeneron is seeking a Senior Manager Statistical Programming for an onsite role in the United States. You will lead the programming aspects of clinical studies, coordinate teams, and ensure deliverables meet regulatory standards.

Responsibilities include mentoring staff, developing data models and standards, and collaborating with project teams to support submissions and reports. A strong background in SAS and regulatory data standards is required.

Qualifications

• Masters Degree with 8-10 years of relevant experience.
• SAS Certification desirable.

Responsibilities

• Coordinate and oversee programming deliverables across studies.
• Lead internal and CRO programming activities and QC.
• Develop standards and macros for regulatory deliverables.
• Mentor junior staff and ensure compliance with data standards.

Skills

Statistical programming

SAS

Project leadership

CDISC

Education

Masters Degree

Job description

Senior Manager Statistical Programming

Please note this is an onsite position and NOT eligible remote.

A Senior Manager Statistical Programming provides timely support to the project team on all programming matters according to the project strategies within a therapeutic area. As an integral part of a project team, the incumbent provides project leadership and contributes to the programming support for processing data from clinical studies. Project requirements will be identified according to a Statistical Analysis Plan, programming specifications or user requirements/design documents using internal standards and guidelines. The incumbent is responsible for leading the programming aspect of the project, both internally or CROs, for all programming deliverables and participates in the identification and development of programming standards and macro development to facilitate the creation of statistical deliverables from a single study through to regulatory approval, product launch, and annual reports. May be asked to oversee special projects / work with clinical task force. Meets statistical adhoc requests of senior management.

As a Senior Manager, A Typical Day May Include

• Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming within a therapeutic area using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Manage and coordinate programming and QC of analysis datasets and TFLs following Regeneron standard data models and/o integration of data across studies in support of CSS/CSE and esub deliverables.
• Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis when programming clinical data or system application deliverables.
• Contribute to programming development and quality control of the programming deliverables utilizing Regeneron tools and methodologies.
• Programming representative within a therapeutic area in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, programming representative for an application development to the user audience.
• Develop data models, programming standards and code, and training end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
• Mentor junior level staff in therapeutic area requirements. Develop collaborative work environment and be a positive role model.
• Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group.

To be considered for this role, you must meet the following requirements

• Masters Degree and 8-10 years of relevant experience
• SAS Certification desirable.

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. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

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)

$150,500.00 - $245,500.00