Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.

Job Description

• Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works with

  project team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments.

  Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters for

  sample size estimation.

• Independently determine appropriate statistical methodology needed in support of study objectives; develops and

  authors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works with

  external partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomization

  schedule as planned.

• Actively participates in meetings to identify scientifically appropriate data collection instruments and database design

  requirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimum

  variance), and satisfy analysis requirements.

• Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach.

• Reviews identified or anticipated technical or data related issues arising in the design, conduct

  or analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to

  address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program

  development of novel statistical methodology.

• Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods and

  relevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables.

• Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol & analysis plans

• Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps

  management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and

  non-routine questions from clients, and independently pursues analyses suggested by the data.

• Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area.

• Maintains technical skills and increases own knowledge of new statistical methodology or areas of

  application through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of the

  statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics department

  standards, GxP compliance, and best operating practices.

Qualifications

This position will be required to sit on-site 3 days / week

This position can be hired at the Manager or Sr. Manager, Statistics level depending on years of experience and education

Qualifications for Sr. Manager, Statistics:

• MS or PhD in Statistics, Biostatistics or a highly related field.

• At least 4-6 years (PhD) or 8-10 years (MS) of experience in pharmaceutical

  development and applied statistics/statistical consulting required.

• statistical modeling and inferential statistics; actively seeks to acquire knowledge

  concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications.

• Pharmaceutical or related industry

  experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in a regulated environment preferred.

Qualifications for Manager, Statistics:

• MS (with 6+ years of experience) or PhD (with 2+ years of experience) in Statistics, Biostatistics, or a highly related field.

• High degree of technical competence and effective communication skills, both oral and written

• Able to perform statistical computations and simulations

• Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others

• Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo

• Pharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment.

Additional Information

AbbVie 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

AbbVie 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.