Sr Director, Statistical Innovation

Research Job Description

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world. In this vital role you will: ·     Provides senior advisory input in the design of therapeutic area and product development strategies, development programs, and clinical studies, in partnership with the Biostatistics TA head, Strategic Development Director, Senior Director-level and Director-level GSLs, EGT functional leaders, and other key stakeholders. ·     Drives consideration of conventional and innovative design options and ensures the appropriate design, estimand, and estimator are selected to meet the study and development objectives. ·     Provides advanced statistical and methodological advice to Senior Director-level and Director-level GSLs and other key stakeholders on complex issues that may affect major development decisions, regulatory interactions, and filings. ·     Guides evaluation of design options by synthesizing and interpreting simulation results, regulatory considerations, operational feasibility, and development objectives. ·     Provides design options and simulation specifications to the Simulation and Modeling team and develops, reviews, and approves the simulation plan and results. ·     Connects insights and lessons across products and programs within a therapeutic area to promote consistency and broader application of innovative design and analysis approaches.

Advises Therapeutic Area and Product Strategy and Study Design ·     Advises Biostatistics TA leaders, Senior Director-level and Director-level GSLs leading large and complex programs, and EGTs on product strategy, development program design, and clinical study design. ·     Promotes conventional and innovative design options and fit-for-purpose analysis approaches that address appropriate clinical and development questions and balance speed, quality, operational feasibility, and cost. ·     Provides senior advisory input in the development and review of the EGP and GSSP to align program design and statistical approaches with therapeutic area strategy, product strategy, and development objectives. ·     Directs, applies, interprets, and communicates modeling and simulation in collaboration with the Modeling and Simulation group, the Analytics group, and other quantitative partners as needed. ·     Review study design options and proposals prior to submission to GDRC and Key Design Elements (KDEs) prior to submission to TA TRC. Provides Advanced Technical and Methodological Expertise ·     Provides advanced technical and methodological expertise to Biostatistics TA leaders, Senior Director-level and Director-level GSLs, EGTs, and governance bodies on innovative study designs, advanced analysis methods, and complex development issues. ·     Advises large and complex programs led by Senior Director-level and Director-level GSLs on statistical and methodological issues that may affect major development decisions, regulatory interactions, and filings. ·     Reviews key development plans and Phase 2 and Phase 3 protocols and provides senior advisory input during TA TRC and other relevant governance reviews. Builds Strategic Partnerships ·     Develops strong partnerships with Biostatistics TA leaders and the Strategic Development Director to ensure an integrated CfDA team approach when consulting with EGTs and therapeutic area leadership. ·     Builds trusted relationships with Senior Director-level and Director-level GSLs and other EGT functional leaders to embed Design & Innovation consultation throughout the end-to-end development process and determine the most effective approach for advising teams. ·     Builds relationships with FSC members and other senior functional stakeholders to support alignment, escalation, and application of innovative design and analysis approaches. Promotes the Advancement of Innovative Designs and Analysis Methods ·     Promotes the advancement and appropriate application of innovative designs and analysis methods across products and programs within a therapeutic area. ·     Connects insights, methods, and lessons across programs to promote consistency, build organizational capability, and enable broader application of successful approaches.

·     Sign-off the simulation plan ·     Advisory input and EGP/GSSP review

·     Design options for ECP ·     Design simulation plan ·     Design and simulation tools ·     Detailed study specific design

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a Sr Director, Statistical Innovation with these qualifications.

Doctorate degree and 5 years of   Statistics/Biostatistics or related subjects with high statistical content OR Master’s degree and 9 years of  Statistics/Biostatistics or related subjects with high statistical content OR Bachelor’s degree and 11 years of   Statistics/Biostatistics or related subjects with high statistical content In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above ·     At least 12 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting ·     Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions ·     Strategic statistical leadership at product level of at least one complex program or multiple programs of moderate complexity

·     Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research ·     Therapeutic area leadership and experience advising large and complex programs across early development, late development, regulatory filing, and post-marketing support ·     Solid real life experience with both conventional and innovative trial designs in different phases of drug development ·     Expertise in advanced statistical analysis methods, and modeling and simulation ·     Knowledge of disease areas and regulatory guidelines ·     Experience in leading regulatory and/or reimbursement submissions ·     Drive for innovation and quick adaptation to new industry trends ·     Well recognized statistical and strategic leadership among statisticians and cross-functional teams ·     External visibility (e.g., through industry committees/forums, links to academia) ·     Scientific research/publications in one or more areas of statistical science

Scientific / Technical Excellence ·     Expertise in statistical principles, methods, and procedures and the ability to instruct others in these areas relating to randomized and non-randomized clinical research ·     Excellent problem solving skills; uses technical expertise to solve real world problems ·     Knowledge of and ability to propose and apply innovative study design and advanced statistical methods Strong oral and written communication skills ·     Ability to communicate complex and nuanced statistical concepts in a concise and impactful way to various audience Strong influencing and negotiating skills Excellent business acumen and strategic thinking People/ Project management ·     Interacts with multiple stakeholder groups with the abilities to advise/ influence / negotiate ·     Organizational savvy; ability to navigate in a large global organization and builds partnership with members in FSC and EGT ·     Demonstrated ability to manage multiple projects and prioritize ·     Ability to lead without direct authority

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 anticipates accepting applications until 08/31; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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. .

223,624.80USD -302,551.20 USD