Manager, Biostatistics

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.

In this role a typical, day may include the following:

• With supervision and guidance from senior departmental staff, providing support to a clinical study team on all statistical matters.
• Working directly with the 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.
• Defending design at management forums (DPR and PRC), including more sophisticated designs.
• With guidance from senior departmental staff, working with SPTs on statistical elements of program strategy.
• Contributing to design of a clinical study and help draft protocols or amendments.
• Performing relevant sample size calculations.
• Developing statistical analysis plan (SAP).
• Performing statistical analysis, prepare statistical methods and results sections for the CSR.
• Providing statistical insight into interpretation and discussion of study results.
• Contributing tables and figures for management presentations. Under general guidance of experienced statisticians, contributing to clinical trial teams.
• Attending GCST and SPT to represent department.
• Independently preparing TFLs to support CSRs, DSURs, IB and other documents.
• Collaborating with Medical Writing and Clinical to ensure tables are complete.
• Supporting TFL production for ISE/ISS for submissions.
• Co-authoring regulatory submissions. Contributing to 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.
• Under general guidance from senior staff, coauthoring regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings.
• Contributing background material for ACMs and design additional analyses for ACM and as required for labeling negotiations under guidance from senior staff.
• Under supervision/guidance of senior department staff, attending pre-IND, EOP2, pre-BLA, label negotiation meetings
• Contributing to and/or leading technical working groups by developing new methodology and conducting simulation studies.
• Contributing to new/revised SOPs and cross-functional EPIC workstreams.

This role might be for you if:

You possess statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data

You are able to work in departmental computing environment and do advanced statistical analyses.

You have familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)

You have ability to clearly describe advanced statistical techniques and interpret results

You have ability to formulate statistical objectives, design, and analyses for complex clinical projects

You have ability to meet timelines for deliverables such as topline results and final analyses.

You have good communication & developing negotiation skills, and are able to manage internal team and CROs

You are fully independent and for implementation of complex studies or indications or key deliverables within the project.

You are able to utilize higher level staff for technical input and brainstorming to implement solutions for moderately complex projects with many people.

You have active research interest in area related to clinical trial.

You will provide technical input/guidance and lead research teams to investigate new stat methods and apply them to trials.

You have ability to make decisions independently for assigned studies or indication and proactively seeking line management intervention where needed to ensure successful outcome with general guidance from senior departmental staff, including project lead statistician, or Therapeutic Area lead biostatistician.

To be considered, a PhD and at least four years of biotech/pharma experience is needed. 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. SAS, S-Plus/R, Sample size calculation software (e.g., East and Nquery)

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-BO1