Senior Principal Biostatistician, Non-clinical Statistics

Novartis Group Companies; Cambridge (MA); On-site; USD 119,000 - 223,000; Full time

Job summary

An innovative firm is seeking a skilled statistician to join its Data Science and Modeling team. This role focuses on developing statistical methodologies for clinical studies, collaborating closely with bioanalytical teams. The successful candidate will contribute to innovative statistical strategies, report writing, and stakeholder engagement. With a strong emphasis on mentorship and innovation, this position offers a unique opportunity to impact the field of biostatistics within a dynamic environment. If you are passionate about driving methodological advancements and have a solid foundation in statistics, this role is perfect for you.

Benefits

Comprehensive health benefits

Paid time off

Potential bonuses

Stock units

Qualifications

• PhD or Master's in Statistics or related field with relevant experience.
• Strong background in statistical methodologies and bioanalytical methods.

Responsibilities

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

Skills

Biostatistics

Statistical Analysis

Programming

Automation

Clinical Trials

Metadata Management

Education

PhD in Statistics

Master's in Statistics

Tools

R

SAS

Python

Job description

Job Description Summary

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

#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 include validation, troubleshooting, and optimization of immunogenicity and pharmacokinetic assays. This role works closely with our PKS clinical bioanalytical team and project teams across disease areas, requiring 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 R&D processes.
2. Develop statistical strategies: For nonclinical and clinical bioanalytical assay development, including study design, protocol development, statistical analysis planning, execution, and interpretation of results.
3. Report writing: Author internal study reports, contribute to regulatory submissions, and co-author publications.
4. Present findings: Clearly communicate statistical analysis results, interpretations, and conclusions to scientists and management.
5. Innovation: Contribute to developing and applying innovative statistical methodologies and automation development.
6. Mentoring: Potentially mentor junior statisticians.

Desirable Requirements:

• Education: PhD or Master's in Statistics, Biostatistics, or related field. PhD with 3+ years of relevant experience or Master's with 6+ years may be considered.
• Technical knowledge: Broader statistical methodology and its application in design and analysis.
• Technical Skills: Expertise in software such as R, SAS, Python.
• Communication: Excellent interpersonal skills for stakeholder engagement.
• Innovation: Ability to drive methodological innovation.
• Language: Fluent in English (oral and written).

Preferred Requirements:

• Experience in pharma or biotech, GxP environment.
• Experience with statistical cut-point calculations in clinical studies.
• Understanding of immunology and immunogenicity principles.

Compensation and Benefits: The pay range is estimated between $119,700 and $222,300/year, subject to adjustments based on market and individual factors. Benefits include potential bonuses, stock units, comprehensive health and financial benefits, and paid time off. Details will be provided upon offer.

EEO Statement: We are Equal Opportunity Employers, committed to diversity and non-discrimination.

Accessibility: We provide reasonable accommodations for individuals with disabilities. Contact us at [e-mail] or [phone].

Salary Range: $119,700 - $222,300

Skills Desired: Automation, Biostatistics, Clinical Trials, Programming, Metadata Management, Statistical Analysis