What are the responsibilities and job description for the Biostatistics Manager position at BioSpace?
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.
Biostatistics ManagerWhat you will do
Lets do this. Lets change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correctly. The Biostatistics Manager will influence study design, defending statistical approaches both internally and externally ensuring strict adherence to all Amgens Policies, SOPs and other controlled documents.
You will also lead on one complex or multiple less complex studies and projects.
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a detail oriented person with these qualifications.
Basic Qualifications
Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
OR
Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date
OR
Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience
Preferred Qualifications
Doctorate in Statistics/Biostatistics with 1 year of post-graduate statistical experience in the pharmaceutical industry or medical researchExcellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc.Experience in designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or AcademiaProactive and efficient in learning emerging adaptive designs and building simulation tools for wide use and applicationsKnowledge of Bayesian statisticsExtensive knowledge of simulation and modeling techniquesWork well with both statistical colleagues and cross functional teamsGood communication skills (written and oral)What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of 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 That May Include
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
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.
Sponsorship
Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.
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.
Biostatistics ManagerWhat you will do
Lets do this. Lets change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correctly. The Biostatistics Manager will influence study design, defending statistical approaches both internally and externally ensuring strict adherence to all Amgens Policies, SOPs and other controlled documents.
You will also lead on one complex or multiple less complex studies and projects.
- Providing statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
- Completing statistical analysis of individual studies/projects
- Publishing applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
- Being familiar with statistical policy and strategy at Amgen
- Staying abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
- Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
- Assisting in the review of Amgen Policies, SOPs and other controlled documents
- Assisting with study and systems audits conducted by Amgen CQA and external bodies
- Serving as team member of change / process improvement initiatives
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a detail oriented person with these qualifications.
Basic Qualifications
Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
OR
Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date
OR
Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience
Preferred Qualifications
Doctorate in Statistics/Biostatistics with 1 year of post-graduate statistical experience in the pharmaceutical industry or medical researchExcellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc.Experience in designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or AcademiaProactive and efficient in learning emerging adaptive designs and building simulation tools for wide use and applicationsKnowledge of Bayesian statisticsExtensive knowledge of simulation and modeling techniquesWork well with both statistical colleagues and cross functional teamsGood communication skills (written and oral)What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of 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 That May Include
- A 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 sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
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.
Sponsorship
Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.