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Associate Director, Safety Statistics
4 months ago
Company Description
AbbVie'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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The Associate Director, Safety Statistics provides scientific and strategic input and safety statistics leadership for assigned clinical development projects. A visible and collaborative role, the Associate Director works in partnership with patient safety, clinical, and regulatory experts to advance medicines to our patients.
Responsibilities:
Lead the Product Safety Team (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.Author and provide strategic input to 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.Lead cross-functional development, delivery, and interpretation of safety outputs, including graphics. Lead cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. 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 (Patient Safety, Clinical Development, Regulatory, Clinical Statistics, and Statistical Programming) to create development strategies for assigned projects. Build interdepartmental relationships.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 department in discussions with regulatory agencies.Lead contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses.Lead within-department initiatives and represent department 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 department 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 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 writtenAble to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from othersAble to build strong relationships with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quoHave strong leadership skills and experience in working/managing cross-cultural or oversea teamsPharmaceutical 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 orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie 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.
