Manager - Safety Statistics and Biostatistics

Safety Statistician, Manager

Career Category

Research

Job Description

Safety Statistician, Manager

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. Amgen’s Center for Design and Analysis Organization has a new opportunity for a Safety Statistician, Manager to provide statistical expertise in support of safety assessment activities across clinical development programs. In this role, you will contribute to the assessment and interpretation of aggregate safety data across multiple studies and products, working closely with Safety Assessment Teams and cross-functional partners. You will apply sound statistical judgment to support safety evaluation and reporting throughout the clinical trial lifecycle.

Responsibilities:

• Provide statistical expertise to support the assessment and interpretation of aggregate safety data across multiple studies and programs.

• Contribute to the development and execution of aggregated safety analysis plans and related safety assessment and reporting activities.

• Perform statistical analyses of safety data, including exploratory analyses, and contribute to the interpretation of results and formulation of conclusions.

• Collaborate with cross-functional partners to provide statistical input into safety assessment discussions and deliverables.

• Support the development and application of statistical methods, tools, and analyses for safety assessment, including data visualizations and advanced analytical approaches where appropriate.

• Apply knowledge of statistical principles, regulatory guidance, and internal standards to ensure quality and consistency of safety analyses.

• Stay current with developments in statistical methodology and analytical innovation relevant to safety assessment.

• Adhere to all Amgen policies and Standard Operating Procedures (SOPs).

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 with 8years of Industrial experience

• Proficient in an analytical application (e.g., R or SAS).

Preferred Qualifications:

• Hands-on experience in statistical design and analysis, and machine learning

• Clinical trial experience within a pharmaceutical or medical research environment.

• Experience in statistical analyses of safety data in a clinical trials setting.

• Experience working effectively in a globally dispersed team environment with cross-cultural partners.

• Proficiency in developing, or supervising the development of, data visualization tools and analytical applications (e.g., R/Shiny) is highly desirable.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

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Experience Level

Mid Level