Manager, Statistics

2 weeks ago

Shanghai, Shanghai, China AbbVie Full time
Job Description

Provide expertise to design, analysis and reporting of clinical trials or other scientific research studies.
Independently develop protocols and/or statistical analysis plans (or product safety analysis plans/integrated
summary of safety analysis plans/analysis plans for GMA evidence generation) with details for programming
implementation. Implement sound statistical methodology in scientific investigations.

  • Identify scientifically appropriate data collection instruments. Identify and report data issues or violations of
study assumptions. Provide programming specifications for derived variables and analysis datasets. Partner with
Data Science in preparing for database lock.

  • Independently perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to
ensure the delivery of high-quality outputs according to agreed-upon timelines. Identify and anticipate issues
arising in the study design, conduct and propose scientifically sound approaches. Evaluate appropriateness of
available software for planned analyses and assess needs for potential development of novel statistical
methodology.

  • Develop 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
study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses
provided.

  • Work collaboratively with multifunction teams. Clearly explain statistical concepts to non-statisticians. Provide
responses to questions, and pursue analyses suggested by data. Support communications between assigned
product team(s) and functional management. Build/drive cross-functional relationships and collaboration.

  • (SSG) Collaborate with cross functional team for benefit-risk planning and assessment. Contribute to crossfunctional
development of output specifications to address both pre-planned safety analyses and ad hoc
requests.

  • (SSG) Collaborate/lead within the Safety Statistics Group to implement strategic initiatives that address
processes related to interpreting, monitoring, assessing, and reporting safety data to characterize the safety
profile of AbbVie products, improve efficiencies, and provide consistency across therapeutic areas.

  • (GMA Stat) In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other
stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility
assessment to identify fit-for-purpose data sources to address research questions, and develop detailed and
actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to
drive decisions.
Qualifications

MS (with 6+ years of experience) or PhD (with 2+ years of experience) in Statistics, Biostatistics, or a highly
related field.

  • High degree of technical competence and effective communication skills, both oral and written
  • Able to perform statistical computations and simulations
  • 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 desired, including experience and understanding of drug
development and life-cycle management in the regulated environment.

  • (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics,
statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and
bias minimization in observational studies preferred.
Additional Information

AbbVie 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.

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