TEMP - Biostatistician

The Biostatistics and Data Management group is looking for a Biostatistician to support Early Clinical Development and Exploratory Sciences. This position is for a statistician with experience in the pharmaceutical/biotechnology sector, to collaborate in cross-functional drug development teams to execute innovative development strategies for compounds entering early clinical development.

In this role a typical day may include the following:

You will work under the direct supervision of permanent statisticians, to work with cross-functional teams to articulate drug development questions. You will assess the feasibility of endpoints and frame statistical approaches to address those questions. You will design clinical experiments and interventional studies to generate the requisite data and analyze the resulting data. You will work with teams to appropriately interpret the results and make decisions. Working with more experienced project statisticians to co-author clinical study protocols, co-author statistical analysis plans, and perform statistical analyses for interim and final reports.

• Under direct supervision and mentorship of senior departmental staff, provide support to a clinical study team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted in a manner that supports planned statistical analysis.
• Under supervision and mentorship of senior departmental staff, participate in preparation of study protocol and amendments.
• Perform relevant sample size calculations and write statistical methodology section of the protocol.
• Review case report form (CRF) and provide comments and feedback.
• Develop statistical analysis plan (SAP).
• Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures and Listings (TFLs).
• Develop data and programming specifications jointly with programmers.
• Using statistical analysis with SAP. Validate analysis programs, review TFLs, prepare statistical methods and results sections for the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results, and work with the study team to move the CSR through review /approval process.

This role might be for you if:

We seek individuals with a PhD or equivalent degree in statistics/biostatistics or related fields OR MS with >3 years work experience.

• Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
• Strong influence and leadership skills, with a track record of collaboration with scientists and researchers at Biostatistician level.
• Proven knowledge of statistical analysis methodologies, experimental and clinical trial design
• Must be able to work efficiently in a fast-paced collaborative environment, with shown critical thinking skills, and effective communication and presentation skills.
• Expertise in statistical software, such as R, SAS, WinBUGS, STAN, and/or Matlab is required
• Experience with linear and nonlinear models, Bayesian methodology, statistical decision theory, modeling and simulation, and model-informed drug development
• Experience in clinical pharmacology studies, pharmacokinetics (PK), and PK/PD modeling

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.