Manager, Statistics (Immunology) (On-Site)

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Description:

Medical Affairs & Health Technology Assessment Statistics (MA&HTA-Stat) is responsible for partnering with AbbVie Medical Affairs (MA), Market Access and Pricing (MAP), and other corporate functions to provide expertise in biostatistics and mathematics. The partnership is realized in the context of a cross-functional, product-oriented effort and includes providing statistical expertise and consultation for all key MA or Health Technology Assessment (HTA) business activities, including but are not limited to MA research proposal reviews, strategic planning and input on TA strategies, real world evidence (RWE) study designs, real world database research, scientific presentations and publications for all therapeutic areas, vendor oversight of study executions, RWE methodology research, evidence evaluations and generations, HTA submissions and response to HTA requests.

Responsibilities:

• Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies or programs and contribute to development of modern program/trial design methodologies with a focus on real world evidence (RWE) gathering, analysis and interpretation. Compliant with applicable corporate and divisional policies, procedures and cultural values.

• Assist or direct the development of scientific protocols, ensuring they are scientifically sound, aligned with the product strategy, and meet scientific and/or applicable regulatory needs. Ensure statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific investigations

• Demonstrate excellent understanding of statistical concepts and methodologies. Take a leadership role in introducing new/novel statistical methodological approaches into 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 implement 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. Demonstrate a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.In collaboration with MA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources to address research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.

• Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided. Ensure timely and quality statistical deliverables. Assist with or represent MA&HTA Statistics in addressing questions at management and/or product review meetings. Provide in-depth scientific/statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.

• Support/Lead MA projects in partnership with MA, Clinical Research and Clinical Statistics to develop scientifically appropriate strategies for evidence generation, including MA studies, presentations, and publications in assigned therapeutic area(s). Support or lead MA&HTA Statistics to provide functional area input for life cycle management of products. Support or lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationship and collaboration.

• Support/Lead HTA submission for optimal reimbursement and product life-cycle management strategy planning and implementation for assigned projects/indications. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans to fulfil the evidence gaps.

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

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

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

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

• Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies highly preferred.

• Able to identify data or analytical issues, and provide solutions by either