Associate Director, Biostatistician - Oncology:
Regeneron Pharmaceuticals, Inc.

894073262
Regeneron Pharmaceuticals, Inc.
Basking Ridge New Jersey
Pharmacy
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Description
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.

Job Duties:
• With minimal supervision and guidance from senior departmental staff, provide support to a clinical study team on all relevant statistical matters. Working directly with the SPT, medical directors and other study personnel, act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. Defend design at management forums (DPR and PRC).
• With guidance from therapeutic area lead, work directly with SPTs on statistical elements of program strategy.
• Contribute independently to design of a clinical study and help draft protocols or amendments. Perform relevant sample size calculations.
• Develop statistical analysis plan (SAP) for complex studies. Perform/oversee statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results. Contributes tables and figures for management presentations.
• Guide staff in clinical trial team representation. Represent department at GCST and SPT. SPT member.
• Independently prepares and/or oversees TFLs to support CSRs, DSURs, IB and other documents. Collaborates with Medical Writing and Clinical to ensure tables are complete. Supports TFL production for ISE/ISS for submissions. Co-authors regulatory submissions.
• Leads contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for ACMs, etc.
• Coauthors regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Will contribute background material for ACMs and design additional analyses for ACM and as required for labeling negotiations. Attends pre-IND, EOP2, pre-BLA, label negotiation and AC meetings.
• Leads and contributes to technical working groups and sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams.
Requirements:
• Knowledge of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
• Knowledge of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data
• Able to work in departmental computing environment, do advanced statistical analyses.
• Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
• Ability to clearly describe advanced statistical techniques and interpret results
• Ability to formulate statistical objectives, design, and analyses for complex clinical projects
• Ability to meet timelines for deliverables such as topline results and final analyses.
• Good communication & developing negotiation skills, and able to manage internal team and CROs
• SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
• Leadership position. Fully independent and responsible for complex indication or a project. Able to handle almost all types of projects and leverage higher level staff for technical input and brainstorming to implement solutions for complex projects. Able to work with considerable ambiguity.
• Ability to inspire internal staff to be active professionally and help them achieve external presence. Good mentorship. Able to represent BDM on initiatives or serve as a leader for initiatives, and able to reach into the organization to accomplish results.
• Proposes ideas for new research or process improvement projects and leads stat teams to investigate. Active research interest in area related to clinical trial. Sufficient experience to review/comment on regulatory guidance.
• Strong leadership skills and ability to lead/oversee the work of others and be accountable for the quality of such work.
• Ability to make decisions independently on complex problems.
• Works independently, connecting with senior departmental staff, including project lead statistician, or Therapeutic Area lead biostatistician, as needed. Will mentor lower level statisticians in their duties.

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.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

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.

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Basic Qualifications
Requirement