Senior Principal Pharmacometrician
Senior Principal Pharmacometrician
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$ 119700 - 222300
1 Vacancy
Job Description
Band
Level 4Job Description Summary
We are 100 quantitative scientists supporting more than 80 clinical development projects in 10 therapeutic areas every day. As a Senior Principal Pharmacometrics Scientist you will be responsible for the discussion and implementation of pharmacometrics methodologies as well as providing pharmacometrics support for regulatory submissions and integrated evidence generation contributing to drug development decisions with internal and external partners.Job Description
Onsite
#LI-Onsite
Cambridge Massachusetts
Your Key Responsibilities:
- Provide global strategic pharmacometrics leadership and support to clinical development programs of low to mid complexity based on relevant technical and disease area knowledge
- Contextualizing the modeling question with the relevance to drug and disease biology
- Developing an understanding of drug development applied to scoping relevant questions for Pharmacometrics analysis
- Communication of modeling to project teams in multiple settings such as decision board meetings small sub-teams etc.
- Drive the pharmacometrics contributions to regulatory/submission strategy and related documents (e.g. briefing books summaries of clinical pharmacology/efficacy/safety responses to Health Authority questions) with oversights
- Assess pharmacometrics requirements insuring the integration of pharmacometrics information into transition of drug development milestones / decision boards
- Contribute to Integrated Evidence generation by leveraging disease progression and Pharmacokinetic-Pharmacodynamic modeling techniques using varied data sources including Real World Data
- Align with the Analytics team (biometrician data management database programming programming medical and scientific writing) on the pharmacometrics strategy execution and delivery of assigned projects
Essential Requirements:
- Ph.D. in pharmacology biology engineering mathematics statistics or a field with significant modeling-related content (or equivalent) with 3 years experience in clinical drug development applying model-based methods using NLME methods and its application in Dose-exposure-response analysis population PK/PD modeling disease progression modeling and clinical trial simulation in academia and/or industry
- Clinical pharmacology statistics and therapeutic knowledge in one or more disease areas
- Diverse experience in pharma industry on incorporation of model-informed drug development (MIDD) strategies into drug development plans across all phases and answering challenging questions on dose and regimen justification study design safety analysis among others
- Ability to develop and deliver clear concise presentations drive discussions and decision making for both internal and external meetings
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $119700 and $222300 per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other benefits. In addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Automation Biostatistics Clinical Trials Computer Programming Metadata Management Statistical AnalysisRequired Experience:
Staff IC
Employment Type
Full-Time
