Biostatistics Senior Manager

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.