Biostatistics Sr Manager

3 months ago

Rockville, United States Amgen Full time

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 experienceOR High school diploma / GED and 12 years of experience


PREFERRED QUALIFICATIUONS

Doctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research OrMasters degree in biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research .Life 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. of regulatory guidelines.Experience working effectively in a globally dispersed team environment with cross-cultural partners.

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 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 now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.com

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.

  • Head of Biopharma Biostatistics and Analytics

    3 weeks ago

    Rockville, Maryland, United States Emmes Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Biostatistics Director to lead our Biopharma team at Emmes. As a key member of our leadership team, you will be responsible for overseeing the strategic and operational direction of our biostatistics and statistical programming activities for our biopharma clients.Key...

  • Senior Biostatistics Director

    3 weeks ago

    Rockville, Maryland, United States Emmes Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Biostatistics Director to lead our Biopharma team at Emmes. As a key member of our leadership team, you will be responsible for overseeing the strategic and operational direction of our biostatistics and statistical programming activities for our biopharma clients.Key...

  • FedHealth Account Manager

    4 weeks ago

    Rockville, United States LCG Full time

    FedHealth Account Manager (Sr. Capture Manager] Rockville, MD LCG is a minority-owned technology consulting firm that has been a trusted partner to more than 40 federal agencies, including 21 of the 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). For over 30 years, LCG has brought digitization and innovation to the Health and...

  • FedHealth Account Manager

    4 weeks ago

    Rockville, United States LCG Full time

    FedHealth Account Manager (Sr. Capture Manager] Rockville, MD LCG is a minority-owned technology consulting firm that has been a trusted partner to more than 40 federal agencies, including 21 of the 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). For over 30 years, LCG has brought digitization and innovation to the Health and...

  • FedHealth Account Manager

    1 month ago

    Rockville, United States LCG, Inc. Full time

    Job DescriptionJob DescriptionFedHealth Account Manager (Sr. Capture Manager]Rockville, MDLCG is a minority-owned technology consulting firm that has been a trusted partner to more than 40 federal agencies, including 21 of the 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). For over 30 years, LCG has brought digitization and...

  • Sr. SDET

    3 weeks ago

    Rockville, United States ConsultNet Full time

    Title: Senior SDET Location: Remote anywhere in the continental US (lower 48 states). Cannot work outside of the U.S. Type: Contract to Hire, Long term Contract Description: We're searching for a Sr. SDET to help a large financial regulator with testing strategy for a digital transformation initiative. The Sr. SDET will support the ongoing testing...

  • Sr. SDET

    1 month ago

    Rockville, United States ConsultNet Full time

    Title: Senior SDET Location: Remote anywhere in the continental US (lower 48 states). Cannot work outside of the U.S. Type: Contract to Hire, Long term Contract Description: We're searching for a Sr. SDET to help a large financial regulator with testing strategy for a digital transformation initiative. The Sr. SDET will support the ongoing testing...

  • Junior Windows Systems Administrator

    4 weeks ago

    Rockville, Maryland, United States The George Washington University Full time

    Position OverviewThe Biostatistics Center, part of The George Washington University, operates as a prominent research establishment in the field of public health.Functions as the primary data coordination hub for extensive multi-center clinical trials and epidemiological investigations supported by federal funding agencies.Recognized leader in the...

  • Senior Linux Systems Administrator

    4 weeks ago

    Rockville, Maryland, United States The George Washington University Full time

    Job Overview Position Summary: The Biostatistics Center (BSC) at The George Washington University is a prominent research facility located in Rockville, Maryland. It plays a crucial role in coordinating extensive multi-center clinical trials and epidemiological studies funded by federal entities, including the National Institutes of Health. As a leader in...

  • Director/ Sr. Director of Finance

    3 weeks ago

    Rockville, United States Joulé Full time

    Job Title: Director/Sr. Director Finance - Life Sciences Location: Rockville, MD Type: Full Time, Salaried with benefits Overview: Join a leading late stage clinical biopharmaceutical company dedicated to developing transformative therapies for serious medical conditions. With a robust pipeline and a commitment to innovation, our client is seeking a...

  • Sr. Instructional Systems Designer

    2 months ago

    Rockville, United States Hendall Inc Full time

    Job DescriptionJob DescriptionOVERVIEWThe Sr. Instructional Systems Designer (Sr. ISD) designs innovative learning products that are instructionally sound, accurate, and engaging. This role will lead the development and delivery of online training, educational resources/tools, and other content for a large government healthcare agency. The ideal candidate...

  • Sr. SDET

    4 weeks ago

    Rockville, United States ConsultNet Full time

    Title : Senior Data SDET (Java) Location : Remote anywhere in the continental US (lower 48 states). Cannot work outside of the U.S. Type : Long term Contract Job Description: We are supporting a Senior Director in the Quality Assurance space, who is looking for a talented, Senior SDET. Our client is currently working on the development of...

  • Sr Sourcing Associate

    2 days ago

    Rockville, United States ALTA IT Services, LLC Full time

    Job Title: Sr Sourcing Associate Location: Remote EST Role Type: 1 Year Contract to HirePlease Note: There are quarterly meetings onsite in Baltimore, MD W2 only / NO Corp to Corp available for this assignmentQUALIFICATION REQUIREMENTS:Required:Bachelor’s degree or equivalent experienceFour (4) to six (6) years’ experience in a relevant functional...

  • Sr Sourcing Associate

    3 days ago

    Rockville, United States ALTA IT Services, LLC Full time

    Job Title: Sr Sourcing Associate Location: Remote EST Role Type: 1 Year Contract to HirePlease Note: There are quarterly meetings onsite in Baltimore, MD W2 only / NO Corp to Corp available for this assignmentQUALIFICATION REQUIREMENTS:Required:Bachelor’s degree or equivalent experienceFour (4) to six (6) years’ experience in a relevant functional...

  • Senior Manager of Integrated Marketing

    3 days ago

    Rockville, United States JOOLA Full time

    Senior Manager of Integrated MarketingJOOLA is seeking for a Sr. Manager of Integrated Marketing that will oversee the development and implementation of paid media and e-commerce marketing strategies across in-bound and out-bound channels and platforms. This role will play a critical role in expanding and strengthening customer acquisition, expanding the...

  • Clinical Research Advisor

    1 week ago

    Rockville, Maryland, United States Guidehouse Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Advisor to join our team at Guidehouse. As a key member of our Clinical Trials Operations team, you will play a critical role in supporting the operational objectives of the National Institute of Mental Health (NIMH).Key ResponsibilitiesCollaborate with Clinical Trials Operations and Biostatistics...

  • Senior Program Manager

    2 weeks ago

    Rockville, Maryland, United States Leidos Full time

    Job SummaryLeidos is seeking a seasoned Sr. Program Manager to lead a high-profile project in the FDA regulatory review process. The ideal candidate will have a strong background in agile project management, IT project management, and regulatory compliance.This is a challenging opportunity to work with a cross-functional team, manage multiple stakeholders,...

  • Senior Quality Assurance Manager

    2 days ago

    Rockville, Maryland, United States Kolon TissueGene, Inc. Full time

    Job Title: Sr. Quality Assurance ManagerKolon TissueGene, Inc. is a pioneering biopharmaceutical company focused on regenerative medicine. We are seeking a highly skilled QA Manager/Senior Manager to lead and oversee our Quality Systems.Key Responsibilities:Collaborate with Manufacturing on product quality planning and improvementsConduct internal and...

  • Evaluation Specialist

    3 months ago

    Rockville, United States BLH Technologies, Inc. Full time

    Job DescriptionJob DescriptionBLH Technologies, Inc., an award-winning company specializing in public health, research, and communications solutions for Federal and commercial clients, is seeking an Evaluation Specialist (ES) to support Federal clients, including those within the National Institutes of Health (NIH). The ideal candidate will have a strong...

  • Sr. Okta Specialist

    4 weeks ago

    Vernon Rockville, United States Infosys Full time

    Job Description Infosys Public Services is seeking a Sr. Okta Specialist to join our Rockville, MD, or Hartford CT Location. Position Description (scope of work or brief narrative): Configure, support, and maintain Okta SaaS/IpaaS cloud services and Data Management systems. Translates business requirements into design specifications and configurations ...