Manager Remote Statistical Programmer Jobs in Michigan

As a Senior Clinical Pharmacologist this individual is expected to plan, design, implement and analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies working with Clinical Pharmacology, Quantitative Pharmacology, Pharmacometrics/Pharmacodynamics (PK/PD), Toxicology, Bioanalytical, Therapeutic Focus areas and Clinical Development / Regulatory

Affairs teams.

This individual contributes to the scientific understanding of PK/PD for assigned projects, based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs, through the application of state-of-the-art knowledge in pharmacokinetics and pharmacodynamics.

A day in the life may look like:

• Plans, designs, implements and analyzes routine Pharmacometrics (PMx) studies to advance scientific knowledge, in collaboration with other team members.

• Performs analyses such as NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses (or work closely with Research Specialist or PMx Stats Programming team) to deliver PMx results, interpretation and discussion.

• Works (or collaborates with Research Specialist or Programming team) to prepare TFLs to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other documents.

• Collaborates with Scientific Writing (and where appropriate with PMx Stats Programming team) to ensure TFLs for PMx reports are complete. Works in conjunction with Scientific Writing, QC and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.

• With close supervision from senior PMx staff, supports preparation of material to be used in regulatory interactions.

• Contributes to preparation of PMx materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings.

• Has understanding of advanced PMx concepts and techniques, such as advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods, Exposure-Response analysis methods, translational modelling/pharmacology, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP.

• Is highly skilled in use of relevant software, including MS-Excel, R, R-Studio, Prism, Phoenix WinNonlin, NLME, STAN and NonMem, working in department computing environment to perform advanced PMx analyses*.

This may be the right role for you if you:

• Are able to serve independently as study CP/QP/PPKPD lead for moderately complex

• Studies or support study CP/QP/PPKPD lead for more complex studies, and to contribute to or lead non-project objectives.

• Are able to communicate effectively with and influence team members from other functions.

• Fully understand processes and are able to represent PMx on process initiatives.

• Beginning to establish own research areas within development sciences.

To be considered for this role you must have:

A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree and at least 3+ years of relevant Clinical Pharmacology experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)