Sr Manager Associate Director Statistics - CMC Hybrid
Sr Manager Associate Director Statistics - CMC Hybrid
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
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 decisionmaking and improve business operation.
- Regularly interact with management of different levels in strategy meetings. Contribute to strategic planning to ensure statistically optimized nonclinical 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.
Qualifications :
*This position is required to sit onsite 3 days / week* Level is determined by years of experience education and relevant experience.
Qualifications for Associate Director Statistics (CMC):
- MS (with 10 years of experience) or PhD (with 6 years of experience) in Statistics Biostatistics or a highly related field.
- High degree of technical competence and excellent communication skills both oral and written
- 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 manage project timeline and quality of deliverables
- Able to build strong relationship with peers and crossfunctional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
- Have strong leadership skills and experience in working/managing crosscultural or oversea teams
- Pharmaceutical or related industry knowledge required including experience and understanding of drug development and lifecycle management in the regulated environment.
- (SSG) Experience leading safetyrelated projects (eg ISS benefitrisk assessment signal detection)
- (GMA Stat) 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 preferred.
Qualifications for Sr. Manager Statistics (CMC):
- MS or PhD in Statistics Biostatistics or a highly related field.
- At least 46 years (PhD) or 810 years (MS) of experience in pharmaceutical
development and applied statistics/statistical consulting required. - statistical modeling and inferential statistics; actively seeks to acquire knowledge
concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications. - Pharmaceutical or related industry
experience with nonclinical clinical or pharmacology studies as appropriate including experience and understanding of drug development in a regulated environment preferred.
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
