The Statistician will be responsible for 
statistical aspects of study design and analysis 
of data from clinical studies conducted for 
regulatory approval or marketing purposes. This 
includes responsibility for design of studies, 
calculating of sample size and power, writing of 
statistical portions of protocol and statistical 
analysis plan, review of protocol and case report 
forms, analysis and interpretation of data, and 
preparation of relevant sections of regulatory 
submissions, reports, and manuscripts. Work and 
progress toward objectives will generally be 
reviewed on a regular basis by the Manager. 

POSITION RESPONSIBILITIES:
• Applies statistical knowledge to the design of 
clinical studies, ensuring that study objectives 
can be met. This requires calculation of sample 
size and power, as well as solicitation of 
appropriate design assumptions from other staff 
and from published literature.
• Prepares relevant sections of protocols, 
especially those detailing the plans for data 
analysis, and justification for the sample size. 
Reviews entire protocol for consistency. 
• Assists in development and review of case 
report forms, ensuring data will be collected 
efficiently and accurately.
• Identifies potential threats to study 
credibility and validity, and works with study 
team to prevent, track, and manage potential 
problems.
• Writes the statistical analysis plan for the 
study, if required. Also writes error-checking 
requirements for the study data.
• Assists study team in responding to questions 
from FDA.
• Uses a variety of statistical methods and 
software tools to analyze and display data from 
clinical and other studies. Methods must be 
appropriate for the kind of data collected, and 
required assumptions must be tested.
• Interprets statistical findings, and ensures 
that regulatory submissions, reports, and 
manuscripts accurately reflect the data collected.
• Validates and provides clear documentation of 
analysis programs.
• Writes portions of Results and Methods sections 
of reports and manuscripts.
• Consults with other (e.g. non-clinical) staff 
on statistical and analysis issues.
• Attends and contributes to project and 
department meetings. 

BASIC QUALIFICATIONS:
• Masters degree in Biostatistics or Statistics. 
A Bachelor’s degree may be considered if the 
applicant is nearing completion of their graduate 
degree.
• Experience and/or education in analysis of data 
from clinical studies.
• Strong applied statistical skills.
• SAS programming skills
• Experience with or education in principles of 
research data management
• Competency in Windows environment and with 
Microsoft Office Tools (Word, Excel) 

DESIRED QUALIFICATIONS:
• Evidence of good oral and written communication 
skills.
• Well-developed interpersonal skills.
• Specific coursework in Clinical Trials or Epidemiology.
• Experience in study design, preferably in the 
medical device or pharmaceutical industries.
• Knowledge of relational database function, and 
SAS Proc SQL. 


APPLICATION INSTRUCTIONS:
To apply, visit: www.medtronic.com/careers/ 
select Requisition #68936 and "Apply to the Job" 
to route your resume directly to the hiring 
department. Email responses or "applications" 
will not be considered for this position. To 
ensure consideration you must apply online via 
the stated instructions listed above.