The Associate Director Biostatistics, General Medicines/Cardiovascular Therapeutic Areas provides leadership and guidance as the statistical expert on a project team or within a therapeutic area.
In this role, a typical day might include:
For one or more projects, be accountable for all statistical aspects of protocols and submissions, including quality, relevance to regulatory perspective, and scientific validity. Responsible for facilitating career development of direct reports and assisting Head of Biostatistics & Data Management (BDM) department and/or Sr. 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:
With minimal direction from departmental management, assume leadership role for providing statistical support to one or more project teams in the creation of a clinical development plan (CDP), study designs, and production of individual protocols. Work with other BDM members or consultants to develop effective statistical approaches applicable to project. Produce or review individual statistical analysis plan (SAP) and planned integrated summaries.
Represents Biostatistics at Global Clinical Subteams and/or Clinical Study Teams.
Interacts with the clinical / regulatory /statistical programming / data management / medical writing functions to design and analyze clinical trials.
Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations.
Contributes to preparation of material for regulatory interactions, including study design and analysis plans drafts, reviewing TFLs used in regulatory meetings, slides for advisory committee meetings, etc.
Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables. Effect consistency of data collection and analysis within project.
Oversee production of the statistical analyses according to SAP. Oversee preparation of the statistical methods and results sections for CSR and overall summaries. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Serve as company statistical representative at regulatory or external meetings.
Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization.
Provide technical direction and mentoring to staff. Maintain awareness of industry standards and regulatory requirements and communicate within team. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation.
Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group. Participates in Regeneron task forces and cross-functional operational excellence initiatives.
To be considered for this opportunity, you must have the following:
PhD or equivalent degree in statistics/biostatistics with >6 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >10 years’ experience.
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Experience with application of technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
Familiarity and experience with regulatory guidelines for drug development, submissions, and statistical practices
Understanding of the drug submission and approval process regionally and globally
Proven ability to effectively represent Biostatistics and Data Management in multidisciplinary meetings
Expertise in statistical software such as SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery) is required
Demonstrated strong leadership, project management, teamwork, and interpersonal skills
Excellent verbal, written & presentation skills
Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
Experience managing direct reports, contractors, teams, and external agencies, such as CROs, consultant groups, and research committees
Ability to work independently
May report to a Sr. Director or above. Requires the ability to influence others to achieve results. May manage subordinates.
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)
$165,900.00 - $270,700.00