Director, Medical Affairs & Health Technology Assessment Statistics (Office-based)

North Chicago, IL

• Function: Research & Development
• Job Type: Full-time

Job ID: R00132120
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.
Job Description
The Director of Medical Affairs & Health Technology Assessment (MA&HTA) Statistics will be responsible for supporting AbbVie’s Medical Affairs activities in the Western European (EU WEC) and Intercontinental (INTERCON) regions. Additionally, this role will assist with the EU HTA Joint Clinical Assessment (JCA). The Director will provide cross-therapeutic area (TA) support for business activities in both regions. This is a visible and collaborative position, working in partnership with MA&HTA Statistics TAs, EU WEC and INTERCON Medical Affairs, Market Access & Pricing (IMAP) HTA, and other key stakeholders. The Director will offer scientific and statistical expertise for drug development and life-cycle management strategies, including the review, design, analysis, and reporting of clinical or other scientific research programs. They will generate scientific evidence to support medical affairs and reimbursement strategies and engage with health technology assessment (HTA) bodies, the medical community, and key opinion leaders (KOLs) regarding the outcomes of these activities. The Director will also evaluate innovative study design and analysis methodologies, focusing on real-world evidence (RWE) gathering, analysis, and interpretation.

This position will work a hybrid work schedule - 3 days in office from the following AbbVie offices:

• Lake County, IL or Florham Park, NJ

KEY STAKEHOLDERS

• Medical Affairs experts
• Clinical development experts
• Statistical programmers
• Data science experts
• Reimbursement Health Authority experts
  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.
• This job is eligible to participate in our long-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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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.htm

Qualifications

• MS (with 12+ years of experience) or PhD (with 8+ years of experience) in Statistics, Biostatistics, or a highly related field.
• Demonstrate a high level of technical competence coupled with excellent oral and written communication skills.
• Skilled in designing both interventional and non-interventional studies. Proficient in descriptive and inferential statistics, statistical modeling, and programming. Expertise in methodologies for confounding control and bias minimization in observational studies is highly desirable.
• Capable of identifying data or analytical issues and providing solutions through personal expertise or by seeking assistance from others.
• A proven track record in supporting Medical Affairs and Health Technology Assessment (HTA) activities is highly desired.
• Experienced in leading cross-functional teams and managing regional collaborations. Strong leadership skills with a history of working with cross-cultural and regional stakeholders. Highly motivated to drive innovation and challenge the status quo.
• Open to learning new knowledge and technology, and eager to adapt and improve. Enthusiastic about innovation with a self-starter attitude to turn possibilities into reality.
• In-depth understanding of the pharmaceutical or related industries, with experience in drug development and life-cycle management within a regulated environment

• Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design, analysis, and reporting of clinical and other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with health authorities, medical community, and key opinion leaders (KOLs) regarding the results of these activities.
• Demonstrate an excellent understanding of statistical concepts and methodologies. Take a leadership role in introducing new/novel study design or statistical methodological approaches into study protocol and/or analysis plans which improve the efficiency and validity of study results. Be able to explain statistical concepts to non-statistician.
• Review identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Select and supervise the evaluation of alternative analysis strategies or other recommendations to address these issues. Evaluate appropriateness of available software for planned analyses and assess needs for potential program development of novel statistical methodology.
• Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings. Present own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.
• In collaboration with Medical Affairs, Clinical Statistics, Data Sciences, Statistical Programming, Market Access and other stakeholders, direct the assessment and evaluation of existing databases, both clinical studies and real-world databases, supervise the conduct of feasibility assessment to identify fit-for-purpose data sources for research questions, and supervise the development of detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions and scientific publications.
• Propose and direct evaluation of alternatives to traditional randomized clinical trials that make use of real-world databases, e.g. electronic health records, insurance claims databases, and/or registries, to fill critical evidence gaps.
• Represent function/department in cross-functional team(s) and ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with the statistical analyses provided. Ensure timely and quality statistical deliverables. Represent MA&HTA Statistics in addressing questions at management and/or product review meetings. Provide in-depth scientific/statistical review for study protocol, scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.
• Lead MA&HTA Statistics group in partnership with Medical Affairs, Clinical Research, Market Access and Clinical Statistics to develop scientifically appropriate strategies for evidence generation, including real-world studies, presentations, and publications in assigned therapeutic area(s). Lead MA&HTA Statistics to provide functional area input for life cycle management of products. Lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationship and collaboration.
• Train and mentor staff on statistical methodology and operations. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
  Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• MS (with 12+ years of experience) or PhD (with 8+ years of experience) in Statistics, Biostatistics, or a highly related field.
• Demonstrate a high level of technical competence coupled with excellent oral and written communication skills.
• Skilled in designing both interventional and non-interventional studies. Proficient in descriptive and inferential statistics, statistical modeling, and programming. Expertise in methodologies for confounding control and bias minimization in observational studies is highly desirable.
• Capable of identifying data or analytical issues and providing solutions through personal expertise or by seeking assistance from others.
• A proven track record in supporting Medical Affairs and Health Technology Assessment (HTA) activities is highly desired.
• Experienced in leading cross-functional teams and managing regional collaborations. Strong leadership skills with a history of working with cross-cultural and regional stakeholders. Highly motivated to drive innovation and challenge the status quo.
• Open to learning new knowledge and technology, and eager to adapt and improve. Enthusiastic about innovation with a self-starter attitude to turn possibilities into reality.
• In-depth understanding of the pharmaceutical or related industries, with experience in drug development and life-cycle management within a regulated environment.