A senior statistical programmer provides timely support to the study team on all programming matters according to the project strategies. 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. Lead all aspects of 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.
- Support and/or lead programmer for programming and QC of analysis datasets, TFL’s or standard tools following Regeneron standard data models or user requirements. Coordination of activities and communicate shifting timelines and achievements.
- 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 esubmission 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.
- Adheres all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.
- Also acceptable – MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related subject area with 3+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. SAS Certification desirable.
- Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
- Strong SAS programming skills, preferably in a clinical data environment.
- Strong understanding of relational database structure.
- Understanding of reporting systems utilizing multiple data delivery applications.
- Experience with implementing standardization methodology.
- Demonstrated teamwork and interpersonal skills. Ability to problem solve. Strong verbal and written communication skills in a global environment.
- Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis) and ability to provide programming support needs for BLA and other regulatory submissions.
- Some experience in project management with supervision. Ability to organize and manage multiple assignments with meaningful timelines for a limited number of personnel.
- Problem solving and innovative skills that demonstrate initiative and motivation.
- Ability to support multiple assignments with challenging timelines.
- Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
- Knowledge in creation of current CDISC data structures.
- SAS, (Base, Stat, Macro, graph).
- May report to a Manager or above
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.