Senior Biostatistician

3-6 years

Not Disclosed

Bangalore

10 Jan. 29, 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 Biostatistician
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-time, Regular
Job Id: R-76298

Company Overview:

At Lilly, we unite caring with discovery to improve lives globally. As a leader in healthcare innovation, we are committed to discovering life-changing medicines, improving disease management, and giving back to communities through philanthropy and volunteerism. We are looking for passionate individuals who share our determination to make a global impact and improve people's lives.

Purpose of the Role:

The Senior Biostatistician plays a critical role in the design and execution of clinical studies. This position involves collaborating with physicians, veterinarians, and medical colleagues to develop statistical trial designs and analysis plans. The Senior Biostatistician is responsible for managing data analysis activities, providing expertise in statistical methods, and ensuring quality control in study data. This role will contribute to the development of medical therapies by interpreting study data and communicating results.

Key Responsibilities:

Statistical Trial Design and Analysis:
- Collaborate with study personnel to provide input on clinical study protocols.
- Design statistical analysis plans (SAP) for clinical trials.
- Select appropriate statistical methods for data analysis.
- Write the statistical sections of protocols and analysis plans.
- Conduct statistical analyses and interpret results once the reporting database is available.
- Collaborate with data management teams to ensure quality assurance in the data collection process.
Communication of Results and Inferences:
- Work with team members to write comprehensive reports and communicate results.
- Contribute to regulatory submissions, manuscripts, and oral presentations at scientific meetings.
- Respond to regulatory queries and interact with regulatory agencies.
- Present findings to stakeholders and provide statistical input during regulatory inspections.
Therapeutic Area Knowledge:
- Maintain an in-depth understanding of relevant disease states and therapeutic areas.
- Enhance customer focus through scientific contributions and collaboration.
Regulatory Compliance:
- Ensure all work is conducted in compliance with applicable corporate, medical, and departmental policies, procedures, and training.

Minimum Qualification Requirements:

Education: M.S. or Ph.D. in Statistics, Biostatistics, or a related field.
Experience: Over 3 years of relevant experience in biostatistics or statistical analysis in clinical research.

Additional Preferences:

Proficiency in SAS programming and other statistical software.
Strong understanding of experimental design and statistical methodologies.
Excellent interpersonal communication skills and the ability to consult effectively with customers.
Proven ability to work well in teams and lead projects.
Strong problem-solving and strategic thinking skills.
Knowledge of regulatory submission processes and related business processes.
Experience in resource management, project management, and innovative approaches to statistical analysis.

Equal Opportunity Employer:

Lilly is committed to fostering an inclusive work environment. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

If you require accommodations to apply for a position, please complete the accommodation request form on our website.

#WeAreLilly

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Senior Biostatistician

Job Description

Company Overview:

Purpose of the Role:

Key Responsibilities:

Minimum Qualification Requirements:

Additional Preferences:

Equal Opportunity Employer:

#WeAreLilly

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