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Featured Employers
Senior Principal Biostatistician
Company: Cardinal Health
Location: Mansfield, MA
Employment Type: Full Time
Date Posted: 05/04/2021
Expire Date: 07/18/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Computers, Software, Construction, Mining and Trades, Engineering, Healthcare, Practitioner and Technician, Insurance, Manufacturing and Production, Executive Management, Quality Control, Research & Development, Medical, Energy / Utilities
Job Description
Senior Principal Biostatistician

The Senior Principal Biostatistician is responsible for leading in-house statistical and analytical services in support of product safety surveillance activities and quality initiatives. This individual provides guidance on standards and processes and/or technical direction within the statistics group to meet business objectives. The Sr. Principal Biostatistician is responsible for following the process for trending customer complaints and reportable events (e.g. adverse events and device malfunctions) and following the process by which complaints are escalated to the corrective and preventive action (CAPA) system. This individual is responsible for executing all complaint trending activities that apply to all products under clinical investigation, manufactured and/or distributed by Cardinal Health as complaint trending is a source for improvement activities and inputs to management review. This position requires comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.

The Senior Principal Biostatistician demonstrates ability to work independently and cross-functionally with the organization. She/he may provide supervision, mentoring, coaching, performance revision, development plans for direct report(s). She/he ensures compliance with the organizations Quality System policies and procedures and applicable external requirements and standards worldwide regulatory agencies and other applicable standards as pertains to medical devices. In addition, this position requires designing and completing both short and long-term projects/assignments as needed.

What Advanced Analytics contributes to Cardinal Health

Advanced Analytics is responsible for applying quantitative methodologies, techniques and tools to develop best in class analytic solutions that solve complex business problems.

  • Works with stakeholders to identify business opportunities, goals, or objectives
  • determines if objectives can be met using an analytical approach and develops hypothesis.
  • Identifies key data requirements and acquires data
  • harmonizes, rescales, and cleans data for statistical techniques
  • applies data visualization techniques to evaluate data for model specification etc.
  • Builds custom quantitative models by applying advanced statistical methods such as causal and predictive modeling, forecasting, data mining, simulation, and/or optimization.
  • Demonstrates the ability to perform validation and testing of models to ensure adequacy and determines need for reformulation.
  • Interprets results of quantitative models, identifies trends and issues, and develops alternatives to support business objectives.
  • Demonstrates ability to clearly and concisely communicate complex information to a variety of audiences and mediums.
  • Partners with stakeholders and technologist to implement/automate/operationalize models into day-to-day business decision making.

Qualifications

  • Bachelors Degree in related field, or equivalent work experience
  • 4+ years experience in related field preferred
  • Advanced Degree in related field preferred

What is expected of you and others at this level

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Participates in the development of policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope
  • Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts as a mentor to less experienced colleagues

Essential Duties and Responsibilities:

  • Demonstrate knowledge of Cardinal Health products and clinical applications of such products
  • Use statistical tools to analyze data, make acceptable decisions and improve process capability. Required ability to develop solutions to a wide range of difficult problems consistent with organization objectives
  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Required ability to lead complex projects of large scope which may have significant and long-term impact (i.e. design and standardization of analytics and safety surveillance processes within the global complaint handling system)
  • Independently determines method for completion of new projects
  • Recommends new practices, processes, metrics, or models
  • Devise new approaches to problems encountered and deliver process improvement projects
  • Participates in the development of policies and procedures to achieve specific goals
  • Receives guidance on overall project objectives
  • Works with associates from all departments, including product safety clinicians, complaint analysts, engineers, regulatory affairs, R&D, and CAPA owners to develop complaint reports that appropriately address different types of inquiries
  • Responsible for the complaint trending and escalation process by continual review of data that is used in trending and compliance with enterprise standards (i.e., calculation of upper control limits and distribution numbers)
  • Required ability to contribute to the development of policies and procedures
  • Generates complaint reports in the appropriate statistical tool, PowerPoint presentations and implements effective data analysis to recognize safety signals associated to post-launch monitoring of products performance in clinical practice (i.e., subject and consequence codes) as derived from data contained in the global complaint handling system
  • Applies standard practices and techniques in specific complaint data requests, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of detailed steps outlined in the complaint trending and escalation process
  • Responsible for generation of complaint reports as requested by auditors and competent authorities with review and input from the complaint handling manager
  • Continuously improves complaint handling reports to meet changing needs of business
  • Responsible for data gathering/reviewing activities from internal and external quality systems sources
  • Under the direction of department management, actively participate in internal and external audits
  • Generation of monthly risk assessment summary that lists each significant complaint trend for the month and improvement of statistical analysis and product trending activities to enhance the product safety surveillance plans as well as complaint surveillance by customer accounts and regions worldwide
  • Responsible for the monthly and quarterly trending reports by manufacturing site, including data extraction with SAS, data cleaning, calculations, graphs and Power Point presentations of data for the quality system management review
  • Assures the data integrity of all output via appropriate verification and validation activities
  • Share technical expertise/train others as needed
  • Responsible for communicating business related issues or opportunities to next management level
  • Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures
  • Responsible for ensuring compliance with quality procedures, laws and regulations of the applicable markets
  • Performs other duties assigned as needed

Education, Training and/or Experience

  • Bachelors Degree in biostatistics or related field, or equivalent work experience; Masters Degree preferred
  • A minimum of 5 years of quality, manufacturing, or regulatory experience in a medical device or pharmaceutical industry
  • Required to possess advanced understanding of biostatistics
  • Required to have excellent written and oral English communication skills
  • Required advanced level use of Microsoft Excel, SAS, MiniTab, and other statistical tools
  • Preferred certifications from American Society for Quality (ASQ), Six Sigma experience, and/or knowledge of Process Excellence tools

Anticipated Pay Range: $124,000 to $230,000

Bonus Eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD, etc

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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