- Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead statistical strategy for project development and regulatory submission.
- Direct and review the development of design, analysis and reporting for clinical or other scientific research programs. Review Protocols, statistical analysis plans, and statistical programming plans.
- 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. Represent DSS on data monitoring committees. Build interdepartmental relationships.
- Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
- Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming, and other stakeholders.
- Train and mentor staff on statistical methodology and operations. May supervise a group of statisticians as a people manager. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
- Develop strategy for data presentation and interference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures, or licensing activities. Build external scientific connections which foster professional development and promote the reputation of the Statistics department.
- Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Represent DSS in discussions with regulatory agencies and on Advisory Committees. Develop an external presence within the statistics community and represent AbbVie on advances and emerging topics.
Qualifications - MS (with 14+ years of experience) or PhD (with 10+ 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 relationships 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 overseas teams Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in regulated environment.
- For people managers, prior experience of people management is required. Key Stakeholders
- Clinical Development experts
- Statistical Programmers
- Data Science experts
- Global Medical Affairs experts
- Regulatory experts
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 Companybelievesingood faith it will pay for this role at the time of this posting based on the job grade for thisposition.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 formofcompensation 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, consistentwithapplicable 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.
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Director, Statistics - East Irvine, United States - AbbVie
Description
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 Director, Statistics provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients.
