Senior Manager Safety Statistics
Senior Manager Safety Statistics
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Salary Not Disclosed
1 Vacancy
Job Description
The Senior Manager Safety Statistics provides scientific and strategic input and safety statistics leadership for assigned clinical development projects. A visible and collaborative role the Senior Manager works in partnership with patient safety clinical and regulatory experts to advance medicines to our patients.
Responsibilities:
- Serve as the Product Safety Team (PST) statistician for one or more clinical development projects. Lead/develop safety statistical strategy for project development and regulatory submission.
- Provide statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions.
- Author the Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) and lead the development of safety data integration specifications in accordance with analysis plan.
- Contribute to strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies.
- Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical Regulatory Patient Safety or GMA) to create development strategies for assigned projects. Build interdepartmental relationships.
- Lead crossfunctional development of output specifications to address preplanned safety analyses and ad hoc requests. Provide sufficient detail to allow programming implementation and ensure all statistical analyses specified in analysis plans are conducted appropriately.
- Lead development and implementation of projectspecific databaserelated activities in collaboration with Data Sciences Statistical Programming and other stakeholders.
- Mentor staff on safety statistical methodology and operations. Gain expertise in innovative safety statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
- Develop safety strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications including tables listings and figures.
- Ensure that all applicable regulatory requirements for work processes are met review regulatory submission documents and represent DSS in discussions with regulatory agencies.
- Lead development by Safety Statistics of benefitrisk planning and assessment including ensuring delivery and interpretation of benefitrisk data displays/analyses.
- Lead withinSSG initiatives and represent SSG on crossfunctional efforts to implement strategic initiatives that address processes related to monitoring assessing interpreting and reporting safety data.
- Stay current with industry trends and practices related to safety.
Qualifications :
- MS (with 8 years of experience) or PhD (with 4 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 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.
Pharmaceutical or related industry knowledge required including experience and understanding of drug development and lifecycle management in the regulated
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
