Biostatistics Manager, Biosimilar Development
Biostatistics Manager, Biosimilar Development
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Job Description
Career Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION
Youve earned your degree. How will you use that achievement to reach your goals Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Biostatistics Manager Biosimilar Development
The Biostatistics Manager in Biosimilar Development coordinates/performs the design statistical analysis and reporting of individual studies represents Biostatistics on study teams and provides statistical input for publications presentations and inhouse decisionmaking.
Responsibilities
- Provides statistical contributions statistical review and quality control of Study Concept Documents (SCDs) protocols randomization specifications Statistical Analysis Plans (SAPs) Table Listing and Graph (TLG) shells Submission Data File (SDF) specifications other keystudy related documentation protocol deviations Data Quality Review (DQR) Flash Memos Clinical Study Reports (CSRs) clinical publications and other communications in close partnership with CROs in a fullservice CRO model.
- Influences study design and defends statistical approaches internally and externally.
- Ensures all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct.
- Oversees the work of outsourcing partners and vendors for statistical services.
- Performs statistical analysis of individual 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 crossfunctional areas to inform and provide sound statistical guidance to teams (e.g. provide 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 crossfunctionally.
- Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice
- Stays abreast of latest developments in the field of statistics in drug development and contributing to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings.
- Participates in the review of CRO Policies SOPs and other controlled document development; contributes to process improvement and operational efficiency.
- Adheres to all Amgen Policies Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.
Basic Qualifications
Doctorate degree
OR
Masters degree and 2 years of statistical experience
OR
Bachelors degree and 4 years of statistical experience
OR
Associates degree and 8 years of statistical experience
OR
High school diploma / GED and 10 years of statistical experience
Preferred Qualifications
- Masters degree in Statistics/Biostatistics or other subject with high statistical content and 2 years of postgraduate statistical experience in the pharmaceutical industry or medical research or
- Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
- Ability to provide sound strategic and statistical input on study/research design to meet project needs regulatory and scientific requirements
- Ability in presenting results and defending statistical findings study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings steering committee meetings ad board meetings or regulatory meetings
- Ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies
- Demonstrated effective communication skills (written and oral)
Thrive
What you can expect of us
As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and wellbeing.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities including:
- Comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts.
- A discretionary annual bonus program or for field sales representatives a salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide shutdowns
- Flexible work models including remote work arrangements where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position
Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.Salary Range
139595.00 USD 170664.00 USDRequired Experience:
Manager
Employment Type
Full-Time
