Senior Manager, Statistics

Company: Disability Solutions
Location: Irvine
Posted on: March 21, 2023

Job Description:

The Senior Manager of Statistics provides scientific and statistical leadership for assigned clinical development projects. A visible and collaborative role that works in partnership with clinical and regulatory experts to advance medicines to our patients. Major Job Responsibilitie s

• Protocols: Play a critical role in study design and protocol development to ensure that study designs and analysis approaches are scientifically sound, aligned with project strategy, meet regulatory objectives, and make optimal use of the data to be collected. Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol. Assist in developing project and functional standards of data collection and analysis and implement these standards.
• Database Activities: Collaborate with Data Sciences, Statistical Programming, and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs. Contribute to data monitoring plans. Develop and implement project-specific data standards. Ensure accuracy and consistency of data released for statistical analysis.
• Statistical Analyses: Demonstrate extensive understanding of statistical concepts and methodology. Perform statistical analyses independently. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Determine the need for development of novel statistical methodology.
• Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analyses. Prepare oral and written reports to communicate results. Represent Data and Statistical Sciences on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and publications with high quality.
• Project Team Involvement: provide statistical input to compound/drug development and align with functional management. Lead communication between assigned project team(s) and department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional management.
• Regulatory Activities: Ensure that all applicable regulatory requirements for work processes are met.
• Compliance: Compliant with applicable corporate and divisional policies, procedures and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the Statistics function. Ensure compliance with department standards, GxP and best operating practices for staff and self. Complete all assigned training on time. --- 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 cross-functional 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 direct experience and good understanding of drug development and life-cycle management in a regulated environment. Key Stakeholders --- Clinical development experts --- Statistical programmers --- Data science experts --- Regulatory experts Applicable to California Applicants Only
  • The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future.
  • The salary range is (minimum: _$110,500_ to maximum:_$216,000__)
  • This job is eligible to participate in our short-term incentive program
  • This job is eligible to participate in our long-term incentive programs
  • We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
    • 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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person's relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)Travel: NoJob Type: ExperiencedSchedule: Full-timeCompensationMinimum Salary $110,500 Maximum Salary $216,000

Keywords: Disability Solutions, Irvine , Senior Manager, Statistics, Executive , Irvine, California