The Biostatistics and Data Management group is looking for a Manager, Biostatistics to support Early Clinical Development and/or Exploratory Sciences. This position is for a qualified statistician with experience in the pharmaceutical/biotechnology sector, to collaborate in cross-functional drug development teams to develop and execute innovative development strategies for compounds entering early clinical development.
In this role, a typical day might include:
- With general guidance from departmental management, assuming leadership role for providing statistical support to aligned project team, including clinical development plans (CDP) and individual protocols.
- Working with other BDM members or consultants to develop effective statistical approaches applicable to project.
- Interacting with the clinical and regulatory functions to define study endpoints and perform relevant sample size calculations; Learning key clinical/regulatory considerations to ensure that planned statistical methods are applicable, and presenting statistical perspective to clients.
- Reviewing statistical analysis plan (SAP) and planned integrated summaries for consistency with overall project objectives.
- Producing and/or coordinating production of statistical summaries, analyses, and related material for submission to regulatory authorities or independent monitoring committees.
- Providing guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL; Assuming responsibility for accuracy of derived variables.
- Effecting consistency of data collection and analysis within project.
- Supervising execution of the statistical analyses according to the SAP; Advising on relevance and interpretation of proposed ad hoc analyses.
- Preparing statistical methods and results sections for CSR and overall summaries; Providing guidance to the clinical and regulatory teams regarding conclusions and inferences from the project.
- Acting as company statistical representative at regulatory or external meetings.
This role may be for you if:
You have knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
You have excellent influence and leadership skills, with a demonstrated record of strong collaborations with clinicians, pharmacometricians, clinical scientists, and other non-statisticians.
You have solid knowledge of statistical analysis methodologies, experimental and clinical trial design
You are able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, and effective communication and presentation skills.
You have experience in clinical pharmacology studies, pharmacokinetics (PK), and PK/PD modeling
To be considered, you'll need a Ph.D. in statistics or related field with at least two years of experience in the biotechnology, pharmaceutical or health related industry, including some interaction with regulatory bodies and leadership/management experience. Experience in SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery) is vital. Experience with linear and nonlinear models, Bayesian methodology, statistical decision theory, modeling and simulation, and model-informed drug development is also ideal.
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.