Associate Director, Statistical Programming
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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
An Associate Director provides leadership and support to the project teams on all statistical programming matters according to the project strategies within therapeutic area(s). The incumbent identifies therapeutic specific requirements and resource requirements within the therapeutic area(s). The incumbent works with management to identify, develop and implement departmental standards, applications, processes, and training. Works with the Biostatistics group to ensure programmer needs are met regarding therapeutic analysis specifications, application and computing environment support. Works with management to ensure implementation of departmental standards and process, and to identify resource needs based on project milestones and deliverables. The incumbent is responsible for screening and interviewing viable candidates for positions within the programming group, both contract and permanent, and is responsible for goal setting and performance management. May be asked to oversee special projects / work with clinical task force
• May oversee all management functions as head of statistical programming
• Manage multiple projects across multiple therapeutic areas following Regeneron standard data models
• Coordinate/delegate management of individual studies to Sr. level programmers regarding programming and QC of analysis datasets and TFLs following Regeneron standard data models and/or integration of data across studies in support of CSS/CSE.
• Manage the development and execution of department function applications
• Coordinate/delegate the management of all aspects of the application lifecycle including user requirements, validation plan/execution, deployment protocols and software development
• Prepare yearly performance appraisals, define career path for associates and identify areas for improvements
• Review and select resumes, screen and interview candidates for contractor and permanent positions
• Manage resource requirements utilizing Regeneron tools and methodologies
Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group.
MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 10+ (12+) 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, preferably multiple, therapeutic areas
• Thorough understanding of relational database structures and their correlation to submission ready database structures. Knowledge of CDISC data structure requirements
• Experience in managing and implementing standard methodology
• Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation.
• Ability to problem solve
• Excellent verbal and written communication skills in a global environment
• Ability to identify and define departmental goals and objectives
• Experience in project management requiring no supervision
• Ability to effectively organize and manage multiple assignments with challenging timelines
• Experience in goal setting and performance management for programming personnel
• Experience in handling disciplinary activities, providing feedback to personnel in a constructive manner and documenting performance issues.
• Experience in delivering one or more submissions to regulatory authorities globally
• Thorough knowledge of regulatory requirements concerning electronic submission standards
• Thorough understanding of pharmaceutical clinical development in one or multiple therapeutic areas (i.e. therapeutic area endpoints, understanding of statistical concepts, techniques and clinical trial principles) and provide leadership for regulatory submissions.
• Leadership experience, especially in the hiring, development, evaluation and support of junior staff and contractors. Ability to mentor programming staff in project management, resource allocation and communication.
• Experience in the development and execution of project user requirements, system design, validation plans, operational and performance protocols, research and development of applications and toolkits for end-users.
• Extensive experience in development of training material
• Ability to project and embody company values in day-to-day operations
• SAS, (Base, Stat, Macro, graph) and S-Plus/R
May report to a director or above. Requires the ability to influence others to achieve results. May manage subordinate supervisors.
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.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.