Director, Biostatistics - Early Clinical Development
The Director, Early Clinical and Translational Biostatistics provides statistical support and leadership for programs entering clinical development and has responsibility for strategic and operational activities. Provides strategic statistical input to early clinical development strategy for novel therapy programs from pre-clinical through clinical Proof-of-Concept (Phase 2). He/She assists and reports to Senior Leadership of Biostatistics & Data Management (BDM), in the development and implementation of how BDM supports preclinical and clinical development and to support departmental scientific policies, operational guidelines, and administrative structure. This role is also responsible for project staffing and for appropriate resource allocation consistent with corporate priorities.
A day in the life includes the following responsibilities:
- Ensures project teams have appropriate statistical input to biomarker strategies and early clinical development plans and ensures project teams have high-quality statistical support for creation of clinical development plans (CDP), study design, and operational aspects.
- Works with scientists in pre-clinical research to ensure appropriate analysis and interpretation of pre-clinical experiments.
- Collaborate with other biostatisticians, quantitative translational sciences, pharmacometrics, clinical outcomes innovation labs, and imaging, to develop statistical methodology to analyze biomarker data and other exploratory endpoints (including data collected from wearables and endpoints derived from imaging analyses).
- For clinical studies, lead all aspects of statistical reporting and ensure compliance with data submission guidelines, including review of documents such as SAPs, Key Results Memos, CSRs, and other results summaries.
- Ensure statistical designs, data collection, analysis methodologies and processes to clearly and robustly address the objectives of preclinical experiments, clinical studies and programs.
- Work with senior management to ensure statistical representation in key project decisions and regulatory meetings, and serve as departmental representative on corporate-wide teams.
- Set strategy for how department will improve technical expertise, and ensure direction and mentoring of staff including professional development, training and compliance.
- Within area of control, harmonize policies with departmental guidelines / SOPs and with industry standards, as well as developing polices promoting application of Regeneron Way in work practices.
- Collaborate closely with Regeneron and partners' leaders to influence, shape, and drive strategies related to integrated development programs
- Contribute to Regeneron task forces and cross-functional operational excellence initiatives.
- Actively participate in statistical conferences, sponsor internal staff to be active at external professional meetings, and proactively seek ways to represent company externally. Supervise performance of team, and proactively address gaps/issues to ensure performance goals/expectations are met.
This job may be for you if you have following:
- PhD in Statistics, Biostatistics or other relevant field with 8+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interaction with senior management and regulatory authorities, history of successful project and people management, and expertise in multiple therapeutic areas
- Experienced working in a fast-paced environment, with excellent judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards
- Outstanding ability to think beyond traditional statistical approaches and bring an integrated quantitative approach to the strategic elements of drug discovery and development, working together with multiple quantitative and scientific disciplines.
- Effective at representing Biostatistics and Data Management in interaction with senior management or cross-functional committees
- Detailed knowledge of preclinical development, biomarker development, and clinical development strategy with the ability to innovatively apply technical principles, theories and concepts to drug development leading to regulatory approvals
- Knowledge of non-parametric, Bayesian, and machine learning methods is a plus.
- Excellent verbal and written communication, and presentation skills.
- Expertise in R, SAS, and other appropriate statistical software.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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. #LI-SC1