Senior Manager, Biostatistics

Job Description

In this role a typical day may include the following:

• With supervision and mentorship from senior staff, provide support to a study team on all statistical matters. Working directly with the medical directors and study personnel, act as liaison to study team, ensuring that the study is conducted in a manner that supports planned statistical analysis. Defend design at management forums (DPR and PRC), including more intensive study designs.
• Work with SPTs on statistical elements of program strategy.
• Contribute to design of a clinical study and help draft protocols or amendments. Perform relevant sample size calculations.
• Develop statistical analysis plan (SAP). Perform statistical analysis, prepare statistical methods and results sections for the CSR. Provide statistical insight into interpretation and discussion of study results. Supplies tables and figures for management presentations.
• Under general mentorship of experienced statisticians, supplies to trial teams. Attends GCST and SPT to represent department.
• Independently prepares 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 submissions.
• Supplies to preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs used in regulatory meetings, slides for ACMs, etc.
• Under general mentorship from senior staff, coauthors regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Will supply background material for ACMs and design analyses for ACM and as required for labeling negotiations under mentorship from senior staff. Under supervision/mentorship of senior department staff, attends pre-IND, EOP2, pre-BLA, label negotiation meetings
• Contributes to and/or supervises working groups by developing methodology and conducting simulation studies. Supplies new/revised SOPs and EPIC workstreams.

This role might be for you if you have:

Knowledge of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariates analyses, sequential methods, and strategies for handling missing data

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 lead Regeneron teams and CROs

SAS, S-Plus/R, Sample size calculation software (e.g., East and Nquery)

Fully responsible for implementation of sophisticated studies or indications or deliverables within the project.

Able to use higher level staff for input and brainstorming to implement solutions for moderately complex projects with many people.

Active research interest in area related to trials. Provides technical input/mentorship and lead research teams to investigate new stat methods and apply them to trials.

Able to represent BDM on initiatives.

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. Incumbents may mentor (Sr) Biostatisticians in their duties.

To be considered, you must have a PhD and at least five years of experience or MS and 11+ years biotech/pharma experience with trial design concepts, such as non-inferiority, methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings

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.