Job Description Summary
This position will be located in Cambridge, MA USA and will not be located remotely.
#LI-Hybrid
About the role:
We are building a novel non-clinical statistics function within our Data Science and Modeling & Simulation team in PK Sciences, as part of Translational Medicine. The successful candidate will assist our GxP bioanalytical team with data visualization and statistical analysis of data, primarily focusing on clinical studies but not limited to them. The ideal candidate has a strong background in bioanalytical methodology, statistical methodology to support clinical immunogenicity readouts, and biology. Contributions in the bioanalytical area include the validation, troubleshooting, and optimization of immunogenicity and pharmacokinetic assays. This role works side-by-side with our PKS clinical bioanalytical team, and project teams in different disease areas across Biomedical Research. This role will also require close collaboration and mutual support within the non-clinical statistics team.
Job Description
Key Responsibilities:
1. Collaboration: Work closely with scientists in the PKS bioanalytical team, project teams, and disease areas to integrate statistical methodologies into research and development processes.
2. Develop statistical strategies for nonclinical and clinical bioanalytical assay development, including but not limited to:
3. Contributions to study design and protocol development consistent with internal best practices;
4. Statistical analysis planning and execution;
5. Preparation and interpretation of study results;
6. Authoring internal study reports, contributions to regulatory submissions, and co-authoring publications.
7. Present results of statistical analyses, their interpretation, and conclusions, to scientists and management in a clear, concise, complete, and transparent manner.
8. Innovation: Contribute to the development and application of innovative statistical methodologies.
9. Automation Development
10. Potentially mentor junior statisticians
Desirable Requirements:
1. Education: PhD or Master's degree required; in Statistics or Biostatistics or related field strongly preferred; PhD with a minimum of 3 plus years of relevant experience or a Master's degree with a minimum of 6 plus years relevant experience may be considered.
2. Possesses technical knowledge of broader statistical methodology, and ability to appropriately apply it in design and statistical analysis for accurate and high-quality results.
3. Technical Skills: Expertise in statistical software and programming languages (e.g., R, SAS, Python).
4. Excellent communication and interpersonal skills, with the ability to engage effectively with diverse stakeholders.
5. Demonstrated ability to drive methodological innovation and apply advanced statistical techniques to complex problems.
6. Fluent in English (oral and written).
Preferred Requirements:
1. Prior experience working in pharma or biotech preferred, in a GxP environment.
2. Prior experience performing statistical cut-point calculations in clinical studies.
3. Experience in clinical protocol and assay support desired.
4. Understanding of basic principles in immunology and immunogenicity.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $119,700 and $222,300/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.
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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range: $119,700.00 - $222,300.00
Skills Desired: Automation, Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis
#J-18808-Ljbffr