ABOUT ABBVIE

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

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DATA AND STATISTICAL SCIENCES INTERNSHIP OVERVIEW

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie’s Experiential Interns.

Data and Statistical Sciences (DSS), is revolutionizing the drug development landscape through strategic leadership and operational excellence. The DSS team pioneers the generation and leverages scientific evidence to provide new treatments that make remarkable impact for patients. Statistical sciences provides statistics support for all phases of clinical development as well as global medical affairs.

The DSS is group is seeking two interns. The two unique projects are detailed below:

Data Modeling

The Intern will work on adaptive designs that may improve the efficiency of drug development and accelerate the approval of new treatments, especially in oncology trials. The adaptive seamless design combining Phases II and III into a single trial has shown a growing interest. Meanwhile, the challenges include but are not limited to dose selection or control arm selection using short-term endpoint or long-term unmatured endpoint, combining of samples/events in Phases II and III stages, trial duration or sample size assessment, and power evaluation. The Intern will help build the theoretical foundation of modeling relationships among clinical endpoints via copula and close the gap between theory and application of parameter estimation from the possibly unmatured Phase II data via bootstrap.

Dose Selection

FDA Project Optimus emphasizes dose selection in oncology drug development and encourages trials that evaluate at least two doses in a randomized manner. To have two or more doses of the experimental drug and build dose selection into part of the pivotal trials and having interim looks to drop dose(s) gradually becomes a popular approach. There are a few versions of multi-arm multi-stage model can be use in this type of design. However, among these MAMS models, to choose a more efficient one and in the meantime, decide the number and timing of the stages (interim looks) for dose selection is essential. The intern will work on comparing stage-wise MAMS and cumulative MAMS approaches, evaluate the impact of the number and timing of the interim looks, and assess how to use a short-term endpoint to choose doses and use a long-term endpoint as the primary endpoint in this MAMS setting. The work will have a broad impact across oncology molecule teams. It can potentially help projects increase the power, save sample size, reduce the duration of clinical trials, and decrease cost.

KEY RESPONSIBILITIES COULD INCLUDE:

• Perform literature review

• Conduct research on one or more statistical topics

• Implement methodologies using R programming

• Present project results and learnings

• Prepare general guidance on the innovative design

MINIMUM QUALIFICATIONS

• Currently enrolled in university, pursuing a PhD in Statistics, Biostatistics, or related fields

• Must be enrolled in university during the internship period

• Completed at least one full year of graduate study prior to the start of the internship

• Demonstrated record of accomplishment

PREFERRED QUALIFICATIONS

• Expected graduation date between August 2023 and December 2025

• Exposure to clinical trial research

• Knowledge and experience related to multiplicity control, group sequential analysis, adaptive design or other advanced designs

• Strong programming background using R

• Excellent communication skills

BENEFITS AND AMENITIES

• Competitive pay

• Travel, transportation and lodging support for eligible students

• Break rooms stocked with complimentary coffee, tea, beverages, snacks, and cold breakfast items

• Onsite café and fitness center

• Exposure to the pharmaceutical industry and different clinical therapeutic areas

EQUAL EMPLOYMENT OPPORTUNITY

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.