Sr Mgr Statistical Programming
Job Title: Sr Manager Statistical Programming
Location: Tarrytown or Basking Ridge
A Sr. Manager 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.
- 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.
- Works independently as well as collaboratively and as a supervisor. Works in accordance with existing policies and standards for application to specific problems or tasks.
- MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 9+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including history of successful project and people management, and expertise in one or more therapeutic areas. SAS Certification desirable.
- 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.
- Extensive experience in development and implementation of standardization methodology in at least one therapeutic area.
- Role model for demonstrating collaborative teamwork. Strong interpersonal skills that demonstrate initiative and motivation. Strong problem solving skills. Excellent verbal and written communication skills in a global environment.
- Experience in pharmaceutical clinical development in at least one therapeutic area (i.e. understanding of statistical concepts, techniques and clinical trial principles) 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.
- Demonstrates ability to effectively organize and manage multiple assignments with challenging timelines and to identify areas for improvement in workflow and tool development to facilitate the process.
- Ability to mentor programming staff in project management, resource allocation and communication.