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- 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 regulatory agencies, medical community, and key opinion leaders (KOLs) regarding the results of these activities.
- 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. Independently select, evaluate 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. Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.
- In collaboration with Global or US MA, Clinical Statistics, 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 for research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
- Evaluate alternatives to traditional randomized clinical trials that make use of real-world data bases, e.g. electronic health records, insurance claims databases, and/or registries.
- Play a key role in the cross-functional team 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. Assist other GMA Statistics colleagues or represent GMA 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 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.
Qualifications - MS (with at least 8 years of experience) or PhD (with at least 4 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 desired.
- Able to identify data or analytical issues, and provide 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
- Willing to learn new knowledge and technology, open-minded and adapting for improvement, enthusiastic about innovation and a self-starter to make possibilities real.
- Have strong leadership skills and experience in managing a programming group. Experience in working/managing cross-cultural or oversea teams.
- Pharmaceutical or related industry experience required, including experience and understanding of drug development and life-cycle management in the regulated environment
- Learns fast, grasps the 'essence' and can change the course quickly where indicated
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 believesingood faith it will pay for this role at the time of this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, and we mayultimatelypay 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/visioninsurance 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 payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensationand benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.
Senior Manager, Statistics - North Chicago, United States - AbbVie
Description
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
Purpose:
Medical Affairs and Health Technology Assessment (MA&HTA) Statistics is responsible for partnering with AbbVie Global and US Medical Affairs and other corporate functions to provide expertise in the area of biostatistics and mathematics. The partnership is realized in the context of a cooperative, product-oriented effort and includes providing statistical expertise and consultation for all key medical affairs or HTA business activities, including but are not limited to MA research proposal reviews, strategic planning and input on TA strategies, real world study designs, real world database research, scientific presentations and publications for all therapeutic areas, vendor oversight of study executions, real world evidence methodology research, evidence evaluations and generations, and HTA submissions.
Job Responsibilities: