Biostatistical Programming Manager

Amgen Inc. Thousand Oaks , CA 91360

Posted 2 months ago

Career CategoryClinicalJob Description

The Biostatistical Programming Manager will work in Amgen's Global Randomization and Blinding (GRB) organization and can be based at Amgen's headquarters in Thousand Oaks, California or at Amgen's South San Francisco or can be remote.

Responsibilities include:

  • Write and validate SAS programs to verify randomization assignments and dose decisions performed by IRT (Interactive-Response-Technologies) system throughout the conduct of the clinical trial.

  • Function as study programmer to manage IRT Data transfer (DTs) activities

  • Provide leadership and primary responsibility for IRT DTs activities including receipt, review, tracking, and delegation of IRT DTs verification requests

  • Maintain IRT DTs application (Wrapper/Bridge tool)

  • Identify and champion IRT DTs process improvements as necessary.

  • Ensure effective procedures are in place for verifying IRT DTs.

  • Ensure Study Randomizers are sufficiently trained to perform IRT DTs verification activities

  • Investigate, research, and develop IRT DTs verification methods to meet Amgen and regulatory requirements

  • Provide cross functional training and/or instruction on topics related to IRT DTs verification.

  • Collaborate with and represent GRB on cross functional teams to ensure the maintenance and continual improvement of procedures and training relating to IRT DTs verification.

  • Arbitrate and consult with cross functional teams on issues related IRT DTs verification.

  • Collaborate with and represent GRB on cross functional teams to ensure the maintenance and continual improvement of procedures and training relating to IRT data verification.

  • Act as a Gatekeeper for IRT data transfers into Amgen sFTP locations.

  • Understand and execute department level macros and utilities

  • Write and validate study level macros and utilities

  • Perform the duties of a Study Randomizer as needed

  • Ensuring randomization requests are consistent with study protocol and study specific IRT Business Requirements

  • Creating and delivering Subject and IP (Investigational Product) Box randomization lists meeting specifications per randomization requests

  • Verifying electronic system loads

  • Ongoing verification of electronic system execution of randomization schedules and dosing algorithms

  • Ensuring procedures are followed to maintain the study blind per Amgen SOPs throughout the life of the study

  • Maintaining accurate and complete documentation of randomization and blinding activities and communications

  • Serving as subject matter expert to impact randomization specifications ensuring optimal randomization strategies for all Amgen studies

  • Providing training to for other randomizers as necessary

  • Identifies areas for improvement and create strategies for implementing process improvements

  • Assist with study and systems audits by Global Compliance Auditing (GCA) and external bodies, and respond to audit questions and findings

  • Participate in the development and review of GRB policies, manuals, standard operating procedures, and other controlled documents

  • Provide support to and mentor more junior programmer

  • Promote and communicate awareness of biostatistical programming and the role of the GRB department in internal and external professional organizations, conferences, training, or meetings

Knowledge:

  • Biostatistical programming using the SAS System version 8.2 and higher

  • Understanding of computer operating systems, including UNIX, preferred

  • Project planning and management

  • Basic understanding of IRT systems, preferred.

  • Drug development process & operations

Basic Qualifications:

  • Doctorate degree in Computer Science, Statistics, Mathematics, or Life Sciences

OR

  • Master's degree and 3 years of Computer Science, Statistics, Mathematics, or Life Sciences

OR

  • Bachelor's degree and 5 years of Computer Science, Statistics, Mathematics, or Life Sciences

Preferred Qualifications:

  • Bachelors or Masters degree in Computer Science, Statistics, Mathematics, Life Sciences or other related scientific subject

  • Six (6) years clinical research and development programming experience

  • Drug Development (pre-, early, late and/or observational) in related industries

  • Project planning

  • Process improvement participation

  • Team participation and effectiveness

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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Biostatistics Manager

Amgen Inc.

Posted 5 days ago

VIEW JOBS 4/17/2019 12:00:00 AM 2019-07-16T00:00 Career CategoryClinicalJob Description Amgen is seeking a Biostatistics Manager at our global headquarters in Thousand Oaks, CA to report into the Director of Biostatistics. The Biostatistics Manager will provide statistical support for a late stage product team and will involve both study-level and product level support including but not limited to serving as the study statistician for on-going clinical trial or observational studies, participation in regulatory and periodical safety submission activities (such as statistical support for integrated analyses or responses to regulatory questions and support for safety reporting activities). Key responsibilities of the Biostatistics Manager include: * Provides statistical contributions, statistical review and quality control of Study Outlines (SO), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Figures, Listing (TFL) shells, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications under the general oversight of a Study Lead Statistician or Global Statistical Lead * Works with statistical programmers to complete statistical analysis of individual studies/projects * Publishes 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) * Provides basic knowledge on drug development and be familiar with related agency guidelines * Stays abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field * Preferred to know about innovative statistical methods including Bayesian adaptive methods and have good programming skills using SAS, R and/or other statistical software * Communicates the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen * Assists in the review of Amgen Policies, SOPs and other controlled documents * Assists with study and systems audits conducted by Amgen CQA and external bodies Basic Qualifications: Doctoral degree in Statistics/Biostatistics and/or other subject with high statistical content OR Currently enrolled in PhD program in Statistics/Biostatistics and/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 and 3 years of directly related statistics experience Preferred Qualifications: * Doctoral degree in Statistics/Biostatistics or other subject with high statistical content or Masters' degree in Statistics/Biostatistics or other subject with high statistical content, and 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research * Designing, analyzing and/or reporting clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia * Life-Cycle Drug Development Experience (Clinical Development and Post-marketing) * Leadership of at least 1 study/project with minimal oversight * Authored a clinical trial or observational study protocol, DRT/DMC charter, statistical analysis plan, clinical study report, and/or manuscript of clinical trial or observational study results * Knowledge of fundamentals of project planning * Effective communication of written and oral statistical information and clinical trial or observational study results * Strong communication and team interactions skills 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. 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. . Amgen Inc. Thousand Oaks CA

Biostatistical Programming Manager

Amgen Inc.