Senior Manager - Safety Biostatistics

What you will do

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. Amgens Center for Design and Analysis Organization has a new opportunity for a Safety Statistician, Senior Manager, to provide independent statistical expertise to our Safety Assessment Teams and biostatistical colleagues in safety data analysis. In this vital role, you will lead the statistical activities related to the assessment of aggregate safety data for multiple studies and products. You will be part of a cross-functional team, which will provide clinical and statistical judgment to evaluate the totality of the information related to ongoing clinical trials safety assessment.

Responsibilities:

• Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide sound statistical guidance for safety assessment.
• Act as an independent statistician, providing objective statistical expertise for the assessment and interpretation of aggregate safety data across multiple studies/products and formulating sound conclusions and recommendations.
• Provide safety statistics expertise on aggregated safety analysis plans (ASAP) and safety assessment and reporting activities across multiple studies/products.
• Develop, maintain, and set standards for associated controlled process documents, including defining best practices for aggregate safety statistical methodologies, and support the development and application of related training and guidance materials across programs.
• Support innovative projects related to technical enhancements for safety assessment, involving data visualizations, decision-making toolkits, and appropriate advanced analytics, including AI integration.
• Maintain familiarity with Amgen statistical policies, strategies, and regulatory guidance, and stay abreast of developments in statistical methods relevant to safety assessment and reporting.

This position is currently located at Amgen India (Hyderabad).

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The statistical professional we seek is strong in the following qualifications.

Basic Qualifications:

• MSc or PhD in Statistics, Biostatistics, or related field.
  • Doctorate degree and 2 years ofexperience OR
  • Masters degree and 4 years of experience
• Proven ability to apply statistical methods in clinical development.
• Proficient in an analytical application (e.g., R or SAS).

Preferred Qualifications:

• Strong technical expertise with hands-on experience in statistical design and analysis.
• Clinical trial experience within a pharmaceutical or medical research environment.
• Experience in statistical analyses of safety data, including application of Bayesian and/or other advanced statistical methodologies in a clinical trial setting.
• Demonstrated ability to work effectively in a globally dispersed, cross-cultural team environment.
• Proficiency in developing, or supervising the development of, data visualization tools and analytical applications (e.g., R/Shiny) is highly desirable.
• Demonstrated interest in, and ability to stay current with, analytical innovation relevant to safety assessment, including advanced analytics and AI-enabled approaches.