Director, Safety Statistics

Company Description

AbbVies 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 peoples 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 Description

The Director, Safety Statistics provides scientific and strategic input and safety statistics leadership for assigned clinical development projects. A visible and collaborative role, the Director works in partnership with patient safety, clinical, and regulatory experts to advance medicines to our patients.

Responsibilities:

Lead the PST statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop safety statistical strategy for project development and regulatory submission.

Direct or provide safety statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions.

Provide strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) and development of safety data integration specifications in accordance with analysis plan.

Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies.

Oversight of the development, delivery and interpretation of safety outputs, including graphics. Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. Oversight to ensure the delivery of high-quality outputs according to agreed-upon timelines

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.

Provide oversight of cross-functional development of output specifications to address pre-planned 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.

Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.

Train and mentor staff on safety statistical methodology and operations. May supervise contract statisticians or junior statisticians. 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 and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses.

Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data.

Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation.

Stay current with industry trends and practices related to safety and potentially represent SSG/DSS on external initiatives to advance the safety discipline and build external scientific connections which foster professional development and promote the reputation of the Safety Statistics department.

Qualifications

MS (with 12 years of experience) or PhD (with 8 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 cross-functional 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 cross-cultural or oversea teams

Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.

Demonstrate extensive understanding of statistical concepts and methodology for analysis of safety data.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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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​

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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 Company’s sole and absolute discretion, consistent with applicable law. ​

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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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html