Layer, Chiang, et al. Genome Biology
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
The Head of Statistical Programming manages the statistical programming group and oversees all programming activities related to clinical program(s), both internally and externally by CROs. The incumbent develops an overall strategy for the programming group and coordinates the effort across therapeutic areas to identify, develop and implement departmental standards, applications, processes and training.
The incumbent provides timely support to the project teams on all statistical programming matters according to the project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level, and working with the department head and Biostatistics group to develop resource strategies.
The incumbent is responsible for goal setting and performance management and acts as mentor within the statistical programming group with regards to project management, people/performance management and implementation of the departmental standards and the relevant SOPs.
JOB RESPONSIBILITIES :
- Oversee the statistical programming function as the head of statistical programming group.
- Manage multiple projects/studies across all therapeutic areas, regarding programming and QC of analysis datasets and TFLs and/or integration of data across studies in support of CSS/CSE.
- Maintain, refine and ensure proper implementation of Regeneron data model and submission and analysis data standards
- Maintain, refine and ensure proper implementation of Regeneron output standards, graphics standards, narrative standards, e-submission deliverables, etc.
- Work with IS/IT to define the BDM statistical system master plan and its implementation.
- Work with other BDM members for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
- Function as a positive role model for setting high expectations for quality, creativity and project ownership.
- Prepare yearly performance appraisals, define career path for associates and identify areas for improvements.
- Plan and coordinate the statistical programming training as appropriate.
- Review and select resumes, screen and interview candidates for contractor and permanent positions.
- Manage resource requirements utilizing Regeneron tools and methodologies.
- Master’s Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
Skills and Experience :
- Minimum of 10 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
- At least 4 years of managerial experience in statistical programming.
- History of successful project and people management, and expertise in one or more therapeutic areas.
- Thorough understanding of clinical trial design and clinical data reporting process, as well as regulatory requirements in electronic data submissions and CDISC standards.
- Experience in regulatory submissions.
- Must be able to work under tight timelines.
- Excellent organizational skills and ability to prioritize tasks.
- Demonstrate good negotiation skills.
- Vendor management experience.
- Excellent communication and interpersonal skills.
- Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.
Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all recruitment agencies: Regeneron is using the agency management company, Candex - www.candex.com. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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