Sr Director, Statistical Innovation

Career Category

Research

Job Description

·    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

What we expect of you

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.

·    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

Preferred Qualifications

·    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

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, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.

Application deadline

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

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.

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Salary Range

223,624.80USD -302,551.20 USD