Senior Principal Biostatistician, Non-clinical Statistics

Novartis; Cambridge (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Principal Biostatistician to join their innovative Data Science team. This role offers the opportunity to work collaboratively on statistical methodologies that drive impactful research in non-clinical and clinical settings. The ideal candidate will possess a strong background in bioanalytical and statistical methodologies, contributing to the development of innovative solutions and mentoring junior statisticians. This is a chance to make significant contributions in a dynamic environment, enhancing the quality of research and development processes.

Qualifications

• PhD or Master's degree required in Statistics, Biostatistics, or related field.
• Minimum 3 years experience for PhD or 6 years for Master's.

Responsibilities

• Collaborate with scientists to integrate statistical methodologies into research.
• Develop statistical strategies for bioanalytical assay development.

Skills

Statistical Methodology

Data Visualization

Bioanalytical Methodology

Statistical Software (R, SAS, Python)

Communication Skills

Education

PhD in Statistics or Biostatistics

Master's degree in Statistics or Biostatistics

Tools

R

SAS

Python

Job description

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Summary
This position will be located in Cambridge, MA USA and will not be located remotely.

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.

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; and
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. Communication: Excellent communication and interpersonal skills, with the ability to engage effectively with diverse stakeholders.
5. Innovation: 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