Associate Director, Biostatistics & Medical Analytics

The Associate Director (Biostatistics) within Medical Analytics, BDM will provide statistical support for assigned product(s)/project(s)/trial(s).

In this role, a typical day might include:

As part of a collaborative team, they will be responsible for implementing the overall strategy of the BDM organization. They will be responsible for following departmental guidelines promoting teamwork, innovation, and motivation. They will provide feedback into, and promote the use of, BDM policies and process improvement work streams (scientific, systems and processes).

Together with BDM, Clinical, Medical Affairs and HEOR colleagues, they will provide strategic guidance for assigned product(s) to clinical studies, publication strategy, HEOR and market access support including defining future research questions, planning and execution of statistical analysis, providing input into Clinical and Medical Affairs strategy and tactics, providing input into and aligning with the publications plan, and supporting HEOR studies and analysis with particular focus on patient-reported outcomes (PRO).

They will need strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical colleagues.  Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen.

This role might be for you if you can:

• Provide statistical support for assigned product(s)/project(s)/trial(s)

• Work with BDM leadership to implement departmental strategy/goals/objectives.

• Working with BDM leadership, assist with the overall strategy for the BDM organization and work closely with Statistical Programming

• Learn and apply leadership techniques to promote teamwork, innovation, and motivation.

• Provide feedback into BDM policies and process improvement work streams (scientific, systems and processes).

• Develop standards within BDM including standard analysis/display catalogues and SAS macro libraries pertaining to assigned areas

• Further the technology, systems, and process infrastructure within BDM.

• Educate and disseminate knowledge throughout the organization for areas within the expertise of BDM.

• Scientific/statistical input into research study design, formulates novel methods to problem solving, and independently develop the statistical analysis plan to implement those solutions.

• Statistical methods to support Clinical and Medical Affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making.

• Statistical methods to support Health Economics and Outcomes Research including meta-analysis, HTA/reimbursement/value dossiers, and real world studies.

• Experience in designing studies using and analyzing patient reported outcomes (PROs).  Experience in development/validation of PROs is a plus.

• Statistical methods to support new studies including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, adaptive studies, pragmatic clinical trials, etc.

• Author the Statistical Analysis Plan (SAP) to define the appropriate statistical analyses to address research questions, specifications for data derivation, specifications for the statistical analysis methodology, and the display shells for the outputs to be generated in collaboration with key stakeholders.

• Perform and/or oversee statistical analyses using SAS to generate tables, listings, and figures for use in reports/publications/presentations for internal and external purposes.

• Ensures quality of deliverables through appropriate testing and active review for completeness and accuracy including oversight of work packages outsourced to CROs (including developing and implementing an oversight plan).

• Maintain up-to-date with state-of-the-art statistical science by participating in scientific societies, constant review of the clinical and statistical literature, and translate and apply relevant innovative statistical methodology to everyday work.

• Strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical audiences.

• Develop strong partnerships within Regeneron, its partner organizations, and external experts and become established as a critical member of the team.

To be considered for this opportunity, you must have the following:

• PhD in statistics/biostatistics/ epidemiology with at least 6 years of experience (or MS with at least 10 years of experience) in generating solutions to problems presented by clinical, medical and commercial personnel within the biopharmaceutical industry.

• Expertise in statistical methods including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on randomized clinical trials).

• Expertise in statistical methods to support Health Economics and Outcomes Research including meta-analysis, HTA/reimbursement/value dossiers, and real world studies.

• Experience in designing studies using and analyzing patient reported outcomes (PROs).  Experience in development/validation of PROs is a plus.

• Expertise in statistical methods to support new studies including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, adaptive studies, pragmatic clinical trials, etc.

• Experience promoting teamwork, innovation, and motivation.

• Experience estimating and planning resource needs and allocation.

• Knowledge of current statistical methods, at least 6 years using SAS (or R) to solve statistical problems, and experience with sample size calculation software (East, PASS, AddPlan, Nquery, etc.).

#GDBDMJobs

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$162,600.00 - $265,400.00