(Senior) Principal Statistician

4-7 years

Not Disclosed

Shanghai Shi

10 Jan. 31, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: (Senior) Principal Statistician
Location: Shanghai, Shanghai, China
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-77167

Company Overview:

At Eli Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our mission is to innovate and bring life-changing medicines to those in need. Our employees are dedicated to improving disease management, advancing medical research, and giving back to communities. We seek individuals who share our determination to make a meaningful impact on global healthcare.

Position Overview:

The (Senior) Principal Statistician will play a key role in supporting the design, execution, and analysis of clinical trials at Eli Lilly. This position involves providing statistical input during protocol development, contributing to data analysis and interpretation, and ensuring compliance with regulatory requirements. You will collaborate closely with cross-functional teams, contributing to the design of studies and the communication of study results. As a senior statistician, you will also mentor and influence team members and contribute to the advancement of statistical methodologies within the company.

Key Responsibilities:

Statistical Trial Design and Analysis:

Provide statistical input into study protocols and designs, ensuring robust methodology.
Be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting critical analysis validation.
Collaborate with Data Sciences teams to ensure high-quality data through the implementation of data quality assurance plans.
Maintain proficiency in statistical methodologies, continuously applying new methods, and justifying the selection of techniques used.
Perform peer reviews of work produced by other statisticians to ensure high standards.
Influence team members on appropriate research methodologies and ensure best practices are followed.

Communication of Results and Inferences:

Work with team members to draft reports and communicate study results effectively.
Take responsibility for communicating study results in regulatory submissions, manuscripts, and oral presentations at scientific meetings.
Respond to regulatory queries and interact with regulatory agencies as required.
Clearly present findings in group settings and one-on-one with key stakeholders.

Therapeutic Area Knowledge:

Develop a strong understanding of disease states, competitive landscapes, and regulatory environments to enhance collaboration and scientific contributions within therapeutic areas.
Ensure that statistical approaches and solutions are aligned with the therapeutic focus of the studies.

Regulatory Compliance:

Perform statistical work in full compliance with corporate policies, medical and local regulations, and departmental processes.
Stay updated with applicable laws and standards to ensure all statistical work meets required regulatory guidelines.

Statistical Leadership and Teamwork:

Apply innovative statistical methods and tools to solve complex research problems.
Lead projects independently, working effectively across teams, and influencing business decisions through technical expertise.
Introduce new scientific methodologies to address critical business needs and support clinical development goals.

Minimum Qualifications:

M.S. in Statistics, Biostatistics, or a related field, with 4 to 7 years of relevant experience or equivalent.
Fluency in written and spoken English, with strong presentation and communication skills.

Preferred Qualifications:

Proficiency in statistical programming languages/software such as SAS, R, Spotfire, WinBUGs, etc.
Strong interpersonal communication skills for effective customer consultation.
Demonstrated teamwork and leadership capabilities.
Deep technical expertise in experimental design and statistical analysis methods.
Self-management skills with a focus on timely, accurate completion of deliverables.
Creativity and innovation in problem-solving and critical thinking.
Experience with business processes associated with regulatory submissions and other key activities.

Additional Information:

This position offers the opportunity to influence clinical development strategy through statistical leadership and collaboration.
Lilly is committed to fostering an inclusive work environment and supporting individuals with disabilities throughout the recruitment process. If you require accommodation, please complete the accommodation request form available on our careers page.

EEO Statement:

Eli Lilly is an Equal Employment Opportunity/Affirmative Action Employer. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

How to Apply:

If you need accommodations to submit a resume for this position, please complete the accommodation request form available on our careers page. For more information about #WeAreLilly and our commitment to diversity and inclusion, please visit our website.

This is an excellent opportunity for an experienced statistician to contribute significantly to the development of life-saving medicines, working alongside a dynamic team at Eli Lilly.

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