Senior Director, Biostatistics, Hematology/Oncology

Location
Tarrytown, NY, United States
Posted
Nov 11, 2020
Ref
19371BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
SUMMARY:
The Senior Director, Biostatistics will lead statistical support and provide statistical leadership for the hematology/oncology therapeutic area. He/She will have responsibility for strategy and operational activities, as well as assisting the Head of Biostatistics in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure. He/She will also serve as senior research specialist, with demonstrated leadership ability within Global Clinical Development (GCD) and within the field for specific statistical methodology or application. The successful candidate should have a track record in leading teams and effectively structuring a function to manage the anticipated growth in the product pipeline. He/She must also possess excellent communication skills to interface with senior leadership on behalf of the department and work closely with medical study directors to provide and receive direction on clinical programs and have the ability to influence the clinical teams.
The Senior Director will be encouraged to promote development of key staff for individual projects or areas; as well as implement and maintain policy for recruitment of high potential staff.

Additional key representative responsibilities will include, but not necessarily be limited to, the following:

Job responsibilities:
  • Supervises staff on all aspects of supporting clinical development programs. Works with functional management from hematology/oncology to ensure teams performing the best studies possible and be accountable for all statistical results in a clinical program and therapeutic area. Lead all aspects of preparation for management forums (DPR and PRC) and defend designs at Senior Management meetings.
  • Works directly with clinical area management and SPTs on clinical development program strategy, contributing to both statistical elements and overall program design.
  • Designs clinical studies and oversees draft protocols or amendments. Performs relevant sample size calculations. Defines methods for statistical analysis plans (SAP) and leads the development of the SAP. Reviews critical documents, such as the Key Results Memos, results section for the clinical study report (CSR), review/approve the CSR, and coordinated summaries. Provides statistical insight into interpretation and discussion of study results.
  • Guides staff in clinical trial team representation. Represents department at SPT for complex program and coordinates staff attending Clinical Study Team. Guides staff on presentations to senior management and enables their success.
  • Leads all aspects of the preparation of material to be used in regulatory interactions, including reviewing analysis plan for TFLs in regulatory meetings, slides for ACMs, etc.
  • Oversees and reviews regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Reviews background material for ACMs and additional analyses as required for labeling negotiations. Provides supervision/mentorship to junior staff attending pre-IND, EOP2, pre-BLA, label negotiation meetings. Attend ACM as company statistics expert.
  • Sets strategy for technical working groups and supervises their progress. Accountable for successful delivery of their results. Supports authoring and implementation of new SOPs and actively leads EPIC workstreams on cross-functional initiatives.

Job requirements:
Education
  • PhD in statistics or related area with 11+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interaction with FDA, EMA and other regulatory agencies, plus a history of successful project and people management (6+ years), and expertise in hematology/oncology.
Experience
  • Works in a changing and fast-paced culture. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks. Works independently - self-directed, high energy and strong work ethic. High degree of adaptability, latitude and attention to detail required.
  • Demonstrated strong leadership, project management, teamwork, and interpersonal skills.
  • Excellent presentation skills.
  • Responds well to questions, speaks clearly and persuasively in positive and negative situations.
  • Demonstrated written and oral communication skills.
  • Listens and gets clarification.
  • Flexibility - Able to adapt to changes in the work environment and manage competing demands. Able to adapt approach or method to best fit the situation.
  • Strives to continuously build knowledge and skills; Shares expertise with others.
  • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance.
  • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
  • Responds to management; takes ownership for actions; keeps commitments; completes tasks on time or notifies appropriate person with an alternate plan.
  • Excellent track record leading and running major process and technology initiatives with utilization and impact across multiple functional groups.
  • Broad knowledge and outstanding understanding of advanced statistical concepts and techniques.
  • Outstanding ability and skills to effectively represent Biostatistics and Data Management in interaction with senior management or cross-functional committees.
  • Thorough knowledge of pharmaceutical clinical development and life-cycle management; ability to innovatively apply technical principles, theories and concepts to clinical drug development leading to regulatory approvals.
  • Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
  • Understanding of the drug development process, regionally and globally.
  • Strong administrative skills.
  • SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and NQuery).
#LI-ET1

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.

-