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
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