Manager Biostatistics (Study Lead Statistician)

Biostatistics Manager

Responsibilities:

• Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols
• Serve as the GBS lead on the Clinical Study Team Leadership Team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
• Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
• Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
• Ensure statistics sections of the TMF are maintained and up-to-date
• Communicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insights
• Contributes to defining signal detection threshold
• Manages self and collaborates closely with peers to ensure timely and quality deliverables
• Reviews deliverables from external suppliers for quality
• Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
• Assisting in the review of Amgen Policies, SOPs, and other controlled documents
• Contributing to process improvement initiatives and operational efficiencies.
• Manage self and other resources according to priorities
• Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgens statistical policies, procedures and strategies.
• Assist with the development and implementation of technology that utilizes AI to streamline statisticians' work.

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

What we expect of you Basic Qualifications

• MSc or PhD in Statistics, Biostatistics, or related field.
• At least 8 years relevant industry experience for the Study Lead Statistician role.
• Experience in machine learning
• Life-cycle drug development experience
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.
• Proven ability to apply statistical methods in clinical development.

Preferred Skills

• Doctorate degree in Statistics/Biostatistics
• Experience in machine learning, real world data analytics, electronic health record data analysis, clinical trial simulation or related applications
• Life-cycle drug development experience
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.