Principal Biostatistician
Principal Biostatistician
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$ 119700 - 222300
1 Vacancy
Job Description
Band
Level 4Job Description Summary
-Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development early development and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements design specifications interface to programmers report programming coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning development & implementation of Industry (CDISC and regulatory) compliant high quality clinical data standards infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use including: -Data standard collection tools in EDC (CRFs edits checks derivations core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure business rules and guidelines.Job Description
Your Key Responsibilities:
- Responsible for all statistical tasks on the assigned trials.
- Protocol development in alignment with the development plan developing statistical analysis plan reporting activities.
- Contribute to planning and execution of statistical analyses and statistical consultation within your cross-functional teams.
- Initiate drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
- Collaborate with clinical regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight.
- Collaborate cross-functionally (e.g. data management programming medical writing) to ensure timeliness and quality of statistical deliverables.
- Contribute to external engagement with consultants advisory boards health authorities congresses and scientific meetings
Video Link position will be located at the East Hanover NJ site and will not have the ability to be located remotely.
Role Requirements:
Essential Requirements:
- PhD with 3 years experience preferred OR MS with 7 years experience
- Fluent English (oral and written)
- Strong communication and presentation skills
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between: $119700 and $222300/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities join the Novartis Network here: is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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
