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Company DescriptionAbbVie'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 DescriptionPurpose:The Associate Director in CMC Statistics is responsible for providing statistical support across a broad range in nonclinical areas with a focus on Chemistry, Manufacture and Control (CMC), expanding and broadening the application of Biostatistics. He/she is also responsible for helping the group head build the group infrastructure (e.g., developing SOPs) and mentor junior statisticians or interns.Responsibilities:
Apply statistical techniques to facilitate better decision-making and improve business operation.
Regularly interact with management of different levels in strategy meetings. Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental and nonclinical SOPs and guidelines. Develop statistical tools to streamline process development, QC testing and troubleshooting.
Collaborate with colleagues from other departments to ensure compliance with regulations and help implement regulatory initiatives such as Quality by Design and process validation. Collaborate with external colleagues on consortia and other research projects relevant to nonclinical topics.
Prepare statistical courses and provide training to scientists. Mentor junior staff, proactively help with both their technical and career development, and seek general feedback and technical input from colleagues.
Develop and deliver statistical and scientific publications and present internally and externally.
Collaborate with other statisticians in improving and sharing statistical approaches.
Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions. Examples of such tools include R, Spotfire, SAS, etc. Continue development of various analysis tools to improve the process.
Proactively seek input and review from other experts within and outside the group on various projects and research activities, and share technical information when appropriate. Proactively propose opportunities for productivity improvements and implementation plans.
QualificationsThis position is required to sit on-site 3 days / weekQualifications:
MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field.
Must have comprehensive knowledge of applied statistical principles & modeling in drug R&D; excellent proficiency in statistical software such as SAS & R; excellent interpersonal and effective verbal and written communication skills; strong programming & computing skills.
Jointly with other project team members, develops and evaluates options for meeting project team goals under time and resource constraints.
Expertise in statistical methodologies such as predictive modeling and inference, machine learning methods, mixed effects models, multivariate analysis, etc.
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Works collaboratively with function management and multiple stakeholders to develop strategies for addressing issues/requirements that arise in clinical, nonclinical or pharmacology programs, as appropriate. Creates a learning environment, open to suggestions for improvement. Embraces other’s ideas, nurtures innovation and manages innovation to reality.
Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development. Pharmaceutical or related industry experience with nonclinical studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred.
Competent in experimental design, statistical modeling and inferential statistics; actively seeks to acquire knowledge concerning the use of new/novel statistical techniques and their biopharmaceutical applications. Productive in relevant statistical research and problem solving.
Key Stakeholders:
Drug product development teams
Product quality experts
Operations experts
Additional InformationApplicable 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, 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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
