Career Category

Scientific

Job Description

The Biostatistics Senior Manager leads key projects and pivotal studies, ensuring all statistical aspects pertaining to clinical activities meet required standards and are statistically correct while influencing study design and defending statistical approaches. The Biostatistics Senior Manager may serve as the safety/filing/regulatory/regional lead and manages technical and best practices oversight for clinical studies.

Experience in oncology/hematology is preferred.

Key activities include:

• Contributes to the statistical theory and the review and interpretation of the statistical results
• Lead and oversee study design (e.g., endpoints) including for outsourced studies
• Contribute to strategy, study design, and statistical analysis by identifying and operationalizing tasks, utilizing existing data or analysis platforms
• Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product 
• Provide statistical consultancy, training, and advice within Amgen
• May serve as the Global Statistics Lead for select products
• Contribute to key design elements, protocols, Statistical Analysis Plans (SAP), Flash Memos, Clinical Study Reports (CSRs), clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents, and other communications for product or study
• Implement standards, technical quality, and consistent approaches to ensure quality of strategy, study design, and statistical analysis for designated products / programs
• Oversee team of statisticians, including from external suppliers, and check their contributions for quality
• Lead efforts in constructing proactive safety surveillance systems and life-cycle safety-related activities for a product as needed

Qualifications:

Basic Qualifications:

• Statistical leadership and contribution to regulatory or reimbursement submissions
• Experience working effectively in a globally dispersed team environment with cross-cultural partners Excellent oral and written English communication skills
• Ability to manage self, lead and manage others in the successful and timely completion of all statistical activities for a study or multiple studies from end to end
• Ability to effectively perform complex statistical analyses and related tasks
• Doctorate in Statistics/Biostatistics or related subject with high statistical content and
• At least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or 

• Master’s degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research.

Preferred Qualifications:

• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
• International collaboration and experience working globally.

Competencies

Scientific / Technical Leadership:

• Leads and deeply understands statistical principles, methods, and procedures.
• Strong analytical and problem-solving skills
• Proficient understanding of drug development process and operations
• Highly proficient in biostatistical software.
• Leads and instructs others in statistical areas relating to randomized and non-randomized clinical research.

People / Project Management.

• Has strong communication skills; Communicates complex and nuanced statistical information in a concise and impactful way, including to lay audiences.
• Plans, schedules, and directs activities of individuals and groups in order to accomplish defined goals and objectives.
• Monitors progress of assigned work and adjusts work efforts accordingly.
• Effectively manages self and others to timely execution of activities.
• Leads and influences internal and external stakeholders.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.