Amgen

Biostatistics Sr Mgr

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 07, 2019
Ref
R-83151
Required Education
Bachelors Degree
Position Type
Full time
The Biostatistics Sr Mgr independently leads a single product, and/or more complex studies and/or projects, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy, and defends statistical approaches internally and externally.
  • Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
  • Plans and executes statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
  • Provides statistical input to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
  • Oversees statistical work performed by study statisticians.
  • Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses, and makes sound conclusions and recommendations.
  • Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provides support and input in case report form design, and data collection).
  • Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
  • Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines.
  • Stays abreast of latest developments in the field of statistics in drug development (eg, innovative trial design)
  • Contributes to process improvement and operational efficiency.
  • Adheres to all Amgen Policies, Standard operation procedures (SOPs).


Basic Qualifications:

Doctorate degree and 2 years of Biostatistics experience

OR

Master's degree and 6 years of Biostatistics experience

OR

Bachelor's degree and 8 years of Biostatistics experience

Preferred Qualifications

  • Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
  • 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
  • 5+ years (doctoral degree) or 8+ years (Master's degree) of post-graduate statistical experience in the pharmaceutical industry or medical research


Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.