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Senior Statistical Analyst (Remote) - job 1 of 2

Job Description

The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.)

Responsibilities

  • Leads the statistical programming activities for projects with lower complexity.
  • Leads the statistical programming activities for studies.
  • Create documentation for regulatory filings including reviewers guides and data definition documents.
  • Leads the development of standard SAS Macros.
  • Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.
  • Develop SAS programs for the creation of ADaM data sets following CDISC standards.
  • Develop SAS programs for the creation of Tables, Listings and Figures.
  • Validation of ADaM data sets, Tables, Listings and Figures.
  • Create specifications for the structure of ADaM data sets for individual studies and integrated data.
  • Participates in the development of standard operating procedures.

This role can be based remotely within the US. If you are located within a commutable distance to an AbbVie office the role may be Hybrid. 

Qualifications

  • MS in Statistics, Computer Science or a related field with 5+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 7+ years of relevant experience.
  • Indepth understanding of SAS programming concepts and techniques related to drug development.
  • Fundamental understanding of CDISC Standards.
  • Fundamental understanding of the drug development process, including experience with regulatory filings.
  • Ability to communicate clearly both oral and written.
  • Ability to accurately estimate effort required for study related programming activities.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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Average salary estimate

$105000 / YEARLY (est.)
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$90000K
$120000K

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What You Should Know About Senior Statistical Analyst (Remote), AbbVie

If you're looking to elevate your career as a Senior Statistical Analyst at AbbVie, you're in for an exciting journey! This remote role is all about diving deep into the research and development of groundbreaking pharmaceutical products. In this position, you will be at the forefront of analyzing and reporting clinical trial data, leading statistical programming activities, and interfacing with key stakeholders across the organization. Imagine the thrill of creating documentation for regulatory filings and developing standard SAS macros - you'll be providing oversight and mentoring to fellow statistical programmers and analysts as you work on projects of varying complexity. Your responsibilities will include developing SAS programs that adhere to CDISC standards to create ADaM datasets and validate outputs like Tables, Listings, and Figures. You’ll not only participate in the crafting of standard operating procedures, but also contribute to innovative solutions that drive our mission forward. A Master's degree in Statistics or Computer Science, combined with your strong SAS programming skills and understanding of the drug development process, will set you up for success in this role. If you have the passion for transforming lives through data and a keen analytical mindset, AbbVie is ready to welcome you to a team that's dedicated to making a difference!

Frequently Asked Questions (FAQs) for Senior Statistical Analyst (Remote) Role at AbbVie
What are the main responsibilities of a Senior Statistical Analyst at AbbVie?

As a Senior Statistical Analyst at AbbVie, your main responsibilities include leading statistical programming activities for clinical studies, creating documentation for regulatory filings, and developing SAS programs for ADaM data sets in compliance with CDISC standards. You will also mentor junior team members and validate outputs to ensure accuracy in clinical trial reporting.

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What qualifications are required for the Senior Statistical Analyst position at AbbVie?

To qualify for the Senior Statistical Analyst role at AbbVie, candidates should possess an MS in Statistics or a related field with 5+ years of relevant experience, or a BS with 7+ years of experience. An in-depth understanding of SAS programming and knowledge of the drug development process, especially regulatory filings, are essential for this position.

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How does the remote work policy work for the Senior Statistical Analyst position at AbbVie?

The Senior Statistical Analyst position at AbbVie can be fully remote within the US. However, if you live within a commutable distance to an AbbVie office, you may have the option to work in a hybrid model, allowing for a mix of in-office and remote work.

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What are the growth opportunities for a Senior Statistical Analyst at AbbVie?

At AbbVie, a Senior Statistical Analyst has excellent growth opportunities, as the company encourages professional development through mentorship programs and training. You will be positioned to lead projects and collaborate with various departments, enabling you to expand your skill set and advance your career in the pharmaceutical industry.

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What software skills are necessary for a Senior Statistical Analyst role at AbbVie?

The key software skills needed for the Senior Statistical Analyst position at AbbVie include proficiency in SAS programming, especially related to clinical data analysis. Familiarity with statistical software, data visualization tools, and an understanding of CDISC standards are also important to excel in this role.

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Common Interview Questions for Senior Statistical Analyst (Remote)
Can you explain your experience with SAS programming specific to clinical trials?

When answering this question, focus on specific projects where you utilized SAS programming for data analysis or reporting in clinical trials. Be sure to mention any standard procedures you followed and how your work impacted study outcomes or regulatory submissions.

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How do you ensure the accuracy of your statistical analyses?

To effectively answer this, share your methods for validating datasets and outputs, such as conducting thorough reviews and implementing standard validation checks. Emphasize the importance of meticulous documentation and cross-verification with team members.

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Describe a challenging project you managed and how you handled it.

Use the STAR method (Situation, Task, Action, Result) to articulate a specific challenge you faced, including the objectives of the project, the steps you took to overcome obstacles, and the positive results that followed. Highlight your leadership and analytical skills.

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What experience do you have with regulatory submissions?

Discuss your prior experience preparing documentation for regulatory filings, including what specific documents you created and the processes you followed. Mention any interaction you had with regulatory agencies and how your contributions facilitated reviews.

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How do you prioritize your work when managing multiple projects?

Explain your approach to project management, such as using task management tools, setting deadlines, and maintaining clear communication with stakeholders. Provide examples of how you successfully balanced competing deadlines in past roles.

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What is your understanding of CDISC standards and their importance?

Demonstrate your knowledge of CDISC standards by explaining their role in ensuring that clinical trial data is submitted in a consistent format. Highlight your experience in applying these standards during data preparation and analysis.

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How do you mentor junior statistical team members?

Share your mentoring philosophy and any strategies you employ to support junior colleagues, such as providing constructive feedback, involving them in complex analyses, and fostering a collaborative environment for learning and development.

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Can you provide an example of how you handled a data discrepancy?

Describe a situation where you discovered a data discrepancy, the steps you took to investigate and resolve the issue, and how you communicated your findings to the team. Emphasize the importance of data integrity and transparency in your work.

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What trends do you see influencing the future of statistical analysis in pharmaceuticals?

Discuss emerging trends in the field, such as the role of machine learning and big data in clinical trials, and share your thoughts on how these advancements can improve data analysis and inform decision-making in drug development.

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Why do you want to work at AbbVie?

Express your enthusiasm for AbbVie’s commitment to innovation and improving patient outcomes. Mention specific projects or values of the company that resonate with you, and explain how your expertise aligns with their goals in the pharmaceutical industry.

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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: i...

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Full-time, remote
DATE POSTED
December 14, 2024

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