Senior Manager Statistical Programming
Senior Manager Statistical Programming
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$ 148300 - 241900
1 Vacancy
Job Description
The Senior Manager provides timely support to the team on all programming matters according to the project strategies within a therapeutic area. As a 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.
In this role a typical day might include the following:
Independently coordinate and oversee the preparation reporting and documentation of project analysis programming 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.
Programming representative 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 project standards to support programming results that follow regulatory submission requirements.
This role may be for you if have:
Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area.
Extensive understanding of relational databases and experience working with complex data systems.
Experience in pharmaceutical clinical development and ability to provide programming support and leadership for BLA and other regulatory submissions.
Experience in working on a submission to regulatory authorities.
Knowledge of regulatory requirements concerning electronic submission standards.
Experience in creation of current CDISC data structures.
Leadership experience especially in the hiring development evaluation and support of junior staff and contractors.
To be considered for this opportunity you must have:
MS. (BS) in Statistics Computer Science Mathematics Engineering Life Science or related field with 9 years of programming experience preferably in processing clinical trial data in the biotechnology pharmaceutical or health related industry. History of successful project and people management and expertise in one or more therapeutic areas.
Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits which often include (depending on location) health and wellness programs fitness centers equity awards annual bonuses and paid time off for eligible employees at all levels!
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 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 Companys business.
For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.
Salary Range (annually)
Required Experience:
Senior Manager
Employment Type
Full-Time
