Manager/Senior Manager, Global Medical AffairsStatistics

About AbbVie
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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Manager/Senior Manager, Global Medical Affairs (GMA) Statistics, Data and Statistical Sciences (DSS), will be responsible for providing analytical support to facilitate the implementation of HTA strategies and HTA submissions. The employee works in partnership with Global Market Access & Pricing (GMAP) HTA Analytics group and other key stakeholders to provide and incorporate HTA requirements in clinical development and life-cycle management strategic plans in a scientific and statistically sound manner.

Responsibilities:

• Working closely with HTA Analytics group, support study design, outcome measures, and statistical methodologies for clinical development programs with a particular focus on HTA requirements, and ensure that they are appropriate, scientifically sound, and consistent with the objective(s) of the scientific investigations.
• Jointly with HTA Analytics group assist or develop program-level Market Access statistical analysis plans to pre-specify afflitate specific HTA requirements, in alignment with internal cross-functional teams.
• Work closely with DSS Clinical Statistics stakeholders and within GMA Statistics to gain TA and domain knowledge with regard to clinical study reports (CSR) and interpretation; understand and leverage existing analysis results from CSRs and GMA led studies to support HTA needs, as appropriate.
• By partnering with the HTA Analytics group, support the identification and recommendation of appropriate statistical analysis methodologies and lead post hoc statistical analyses of clinical trial data and relevant real-world data sources to generate payer evidence and support HTA submissions; contribute to the Core Value Dossier (CVD) preparations, HTA re-assessments, and inquiries from HTA bodies.
• Maintain technical skills and increase own knowledge of new statistical methodology and HTA environment with a focus in the areas of HTA application through scientific literature and attendance at professional meetings. Present own statistical research or review of the statistical literature at meetings and seminars.
• Train and mentor staff on general and HTA specific statistical methodology and HTA operations. Serve as internal subject matter expert for HTA related statistical methodoligies and share best practices. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.

Qualifications

Manager, Statistics:

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

Senior Manager, Statistics:

• MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a highly related field

Additional Qualifications:

• Demonstrate high degree of technical competence in statistical concepts and methodologies; Excellent communication skills, both oral and written; Be able to explain statistical concepts to non-statistician
• Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
• Knowlege in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of HTA statistical methodologies and global healthcare systems desired.
• Programming knowledge and experience with SAS and/or R required
• 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
• 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 working/managing cross-cultural or oversea teams

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.