Abbott Senior Biostatistician in Plymouth, Minnesota
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Primary Job Function:
Assist on the design, analysis, interpretation and documentation of statistical results. Provide statistical consultation to technical staff, management, and regulatory agencies. Responsible for the development of statistical procedures to ensure consistency and use of most adequate statistical techniques division wide. Develop statistical material and provide training to statisticians and non-statisticians.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Responsible for design and statistical methodology selection, sample size justification, randomization order and protocol acceptance criteria.
Provide appropriate statistical input into study design analysis of data. Ensures that statistical sections of protocol-directed clinical studies; design verification; design validation; characterization; and/or research studies are designed to establish or validate product performance claims and/or meet other study objectives; Ensuring clear achievable purpose and scope.
- Statistical Data
Assist study owners on implementing statistical methodologies as defined in the protocol and on defining alternative analysis strategies when changes are needed.
Assist on data analysis and results interpretation.
Assist on the software validation of statistical programs.
Assist project team on data interpretation, inferences and documentation of statistical results.
Participates in the preparation of data for publications and/or regulatory submissions
Assist peers to develop efficient designs, protocols and reports per agreed timelines.
Presents statistical concepts and arguments to management, regulatory agencies and scientists.
Effectively represent the Statistical group on cross functional initiative teams.
- Training, Mentoring
- Develop statistical modules and provide formal training to statisticians and non-statisticians.
- Project Coordination and Regulatory Activities
- Responsible for the accuracy and appropriateness of statistical inputs provided for regulatory submissions and development decisions.
- Problem Solving:
Identifies issues, problems, or opportunities and determines whether action is needed.
Encourages others to generate options for action to address and issue or problem.
Encourage boundary breaking by challenging colleagues to question established work processes.
Position Accountability / Scope:
Effective communication with various levels of personnel is required regularly.
Work collaboratively with multiple stake holders to develop scientifically appropriate strategies.
Effectively and persuasively presents statistical concepts and arguments to management, regulatory agencies, scientists and non-scientists.
Accountable for proper use of clinical statistics and for the validity of conclusions drawn.
BS in Statistics or related field with 6+ years, or MS with 2+ years, or PhD with related work experience or an equivalent combination of education and work.
Minimum Experience / Training Required:
High degree of technical competence and communicative ability, both oral and written.
Competent in experimental designs, sampling plans, equivalence studies, confidence and reliability testing and statistical analysis for test method evaluation
Knowledge in appropriate statistical software such as JMP, Minitab or SAS
Experience in clinical statistical programming, statistical writing, data analysis, data management processes.
- Comprehensive knowledge of business concepts, procedures, practices, unit functions and cross group dependency/relationships.
Experience working with complex problems where analysis of situations and data requires in-depth evaluation of various situations.
Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ability to interface with a variety of management levels on significant matters, often requiring the coordination across organizational units.
Participates in the development of others by facilitating training and providing feedback and guidance. Could act as a mentor to less-experienced staff.
Willing and capable of leading a team.
Plans and organize project assignments of modest variety and complexity.
Ability to initiate and maintain schedule for projects and milestones.
Work without appreciable direction.
Seeks guidance as needed.
OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com