Senior Director, Biostatistics

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 210,000 - 320,000; Full time

Job summary

Amgen is seeking a Senior Director, Biostatistics to provide strategic statistical input and lead a team of biosimilars biostatisticians. You will oversee CROs, enhance statistical methods, and shape regulatory strategies across biosimilar programs.

You will manage staff, collaborate with leaders, and contribute to trial design, analysis plans, and regulatory submissions, helping to advance medicines for patients worldwide.

Qualifications

• Doctorate degree and 5 years of Senior Director, Biostatistics experience
• OR Masters degree and 9 years of Senior Director, Biostatistics experience
• OR Bachelors degree and 11 years of Senior Director, Biostatistics experience
• At least 5 years experience directly managing people and/or leadership experience

Responsibilities

• Provide oversight for protocols, SAPs, flash memos, study reports and regulatory communications.
• Develops and maintains statistical excellence in design, analysis and reporting for biosimilar development.
• Ensures standards, quality and consistency in clinical development strategy and statistics.
• Provides statistical input into regulatory strategies and submissions for regulatory authorities.
• Oversees staff and CROs to deliver study deliverables on time and to quality standards.
• Responsible for hiring, allocation and development of statistical staff and budgets.
• Leads development and review of Policies and SOPs with CROs and Amgen Biosimilar Development.
• Publishes applied research and shares statistical methodology at scientific meetings.

Skills

Leadership

Biostatistics

Regulatory submissions

Data analysis

Education

Doctorate in Statistics/Biostatistics

Masters degree

Bachelors degree

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Director, Biostatistics

What you will do

Lets do this. Lets change the world. In this vital role you will provide strategic statistical input to and oversees all statistical aspects of biosimilar development for all products; leads, manages and develops the team of biosimilars biostatisticians; oversees the performance of biostatisticians in Contract Research Organizations (CROs); enhances statistical understanding within Biosimilar Development; develops innovative methodologies and study designs for biosimilars; and assists the head of Biostatistics and Statistical Programming in leading the department.

Responsibilities

• Provide oversight for protocols, Statistical Analysis Plans, Flash Memos/Summary of Report, Clinical Study Reports, submission documents, correspondences with health authorities, clinical publications, reimbursement documents and other communications.
• Develops and maintains successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development. Provides strategic statistical input and is a major contributor to clinical development plans.
• Ensures standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis; maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results; and contributes to statistical strategy in Amgen's Biosimilar Development.
• Ensures excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentation/publication. Represents Biosimilar Development on statistical matters at meetings with regulatory authorities, key opinion leaders and similar other expert bodies and defends statistical approaches internally and externally.
• Provides oversight and guide to staff members within Amgen and in CROs in completing study deliverables according to agreed timelines following quality standards.
• Responsible for hiring, allocation, management, and development of internal statistical staff, and contributes to developing and managing goals, budgets and resource plans.
• Leads and/or participates in the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen's Biosimilar Development for process improvement and operational efficiency.
• Promotes, communicates, and becomes an expert in specific statistical methodologies. Publishes applied research in scientific journals and books and gives presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings. Stays abreast of and contributes to scientific advances in the field.

• Develops and maintains long-term relationships with key statistical opinion leaders, including academics, regulators and other industry leaders.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a Senior Director, Biostatistics with these qualifications.

Basic Qualifications:

Doctorate degree and 5 years of Senior Director, Biostatistics experience
OR
Masters degree and 9 years ofSenior Director, Biostatistics experience
OR
Bachelors degree and 11 years of Senior Director, Biostatistics experience
In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Established records of strong leadership and people management skills
• Statistical leadership to regulatory submissions, including advisory committees
• Demonstrated effective communication skills including statistical strategy (written and oral)
• Doctorate in Statistics/Biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research Or

Masters degree in Statistics/Biostatistics and at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research

• Ten years of post-graduate statistical experience in the pharmaceutical industry
• Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies
• Life cycle Drug development experience (Pre-clinical Development, Clinical Development, and Post-marketing), hence knowledgeable of the processes and operations
• Demonstrated leadership attributes: charts the course, develops best teams, role model
• Knowledge/experience of Biosimilars development, including global regulatory requirements and design and analysis of non-inferiority and equivalence trials