Amgen
Biostatistics Sr Manager
Amgen, Rockville, Maryland, us, 20849
Position Summary:
The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
Responsibilities:Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business DevelopmentProvide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needsServe as primary author for statistical sections of protocolCreate accompanying statistical documents (e.g., statistical analysis plan and mocked shells)Participate in development of EDC database and interactive response technology (IxRS) specificationsCollaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functionsImplement innovative statistical techniques that will provide benefit to clinical development programsContribute to strategic planning and go/no go decision guidanceReview biostatistics and statistical programming tasks outsourced to vendorsPerform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if neededSupport the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if neededEnsure timeliness and quality of deliverablesTravel as needed to execute assigned responsibilities.
BASIC QUALIFICATIONS
Doctorate degree and 2 years of experience OR Masters degree and 6 years of experience OR Bachelors degree and 8 years of experience OR Associates degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
PREFERRED QUALIFICATIONSDoctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical researchMasters degree in biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical researchLife Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)Strong verbal and written communication combined with organizational skills and cross-cultural sensitivityStatistical leadership and contribution to regulatory and reimbursement submissions.Experience working effectively in a globally dispersed team environment with cross-cultural partners.
ThriveWhat 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 well-being.
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 sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor 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.#J-18808-Ljbffr
The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
Responsibilities:Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business DevelopmentProvide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needsServe as primary author for statistical sections of protocolCreate accompanying statistical documents (e.g., statistical analysis plan and mocked shells)Participate in development of EDC database and interactive response technology (IxRS) specificationsCollaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functionsImplement innovative statistical techniques that will provide benefit to clinical development programsContribute to strategic planning and go/no go decision guidanceReview biostatistics and statistical programming tasks outsourced to vendorsPerform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if neededSupport the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if neededEnsure timeliness and quality of deliverablesTravel as needed to execute assigned responsibilities.
BASIC QUALIFICATIONS
Doctorate degree and 2 years of experience OR Masters degree and 6 years of experience OR Bachelors degree and 8 years of experience OR Associates degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
PREFERRED QUALIFICATIONSDoctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical researchMasters degree in biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical researchLife Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)Strong verbal and written communication combined with organizational skills and cross-cultural sensitivityStatistical leadership and contribution to regulatory and reimbursement submissions.Experience working effectively in a globally dispersed team environment with cross-cultural partners.
ThriveWhat 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 well-being.
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 sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor 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.#J-18808-Ljbffr