Job Description
The Director of Biostatistics Internal Medicine provides leadership and guidance as the statistical expert on a project team or within a therapeutic area, e.g., Infectious Diseases and other broader areas in Internal Medicine.
In this role, a typical day might include:
For one or more projects, be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within company. Responsible for project staffing, resource planning and allocation within therapeutic area(s). Responsible for facilitating career development of direct reports and assisting VP, BDM and/or Dr. Director, Biostatistics, with creation and implementation of policies. May have management responsibility. In some cases incumbent could serve as department leader in specific technical area.
This role might be for you if you can:
• Determines in conjunction with department Vice President, department goals, and resource allocation.
• Oversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other BDM departmental members or consultants, to develop effective statistical approaches applicable to project.
• Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries. Review and approve topline results memos and statistical conclusions. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings.
• Provide general guidance on definition and documentation of key derived variables needed to support production of tables, figures, and listings (TFL). Effect consistency of data collection and analysis.
• Plan and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity.
• Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation.
• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance.
To be considered for this opportunity, you must have the following:
• PhD in Biostatistics, Statistics, Mathematics or related field with >8 years of experience or an MS Degree with >12 years.
• Proven experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful people management, and expertise in one or more therapeutic areas.
Please note, this role requires you to work in a onsite weekly hybrid model out of our New York, New Jersey, Dublin or UK offices. If you are not local and qualify, we can offer a relocation package!
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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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)