The Senior Principal Statistician will be 
responsible for statistical aspects of study 
design and analysis of data from multiple complex 
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 will 
generally be self-directed, but will be reviewed 
by the Manager/Director at key time points. The 
Senior Principal Statistician will be expected to 
provide leadership to study teams and to other 
statistical staff, and may be assigned to lead 
groups of statisticians on one or more large 
projects. This position exists primarily for 
highly experienced Statisticians who choose to 
continue in the technical track rather than 
pursue a management position, or who are awaiting 
a management opportunity. 

POSITION RESPONSIBILITIES:
• Applies statistical and clinical trials 
knowledge and experience to provide leadership in 
the design of complex clinical studies, ensuring 
that study objectives are appropriate and can be 
met. This requires calculation of sample size and 
power, as well as determination of appropriate 
design assumptions 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.  
• Takes a leadership role in responding to 
relevant questions from FDA and FDA Advisory 
Panels, and in negotiations with FDA regarding 
study design and interpretation.
• Uses a variety of statistical methods and 
software tools to analyze and display data from 
clinical and other studies, including interim 
analyses and other advanced methods. Methods must 
be appropriate for the kind of data collected, 
and required assumptions must be tested.
• Interprets statistical and clinical findings, 
and ensures that regulatory submissions, reports, 
and manuscripts accurately reflect the data 
collected. Anticipates and responds to challenges 
to study results and interpretation.
• Validates and provides clear documentation of 
analysis programs.
• Writes Results and Methods sections of reports 
and manuscripts as needed.
• 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 
with at least 12 years of experience in analysis 
of data from clinical studies and design of 
clinical trials or other statistical experience 
in the life sciences. SAS or other statistical 
analysis software experience. 

DESIRED QUALIFICATIONS:
High level of competency in Windows environment 
and with Microsoft Office Tools (Word, Excel). 
Demonstration of good oral and written 
communication skills. High level of knowledge of 
clinical trial methods and execution. High degree 
of expertise regarding research data management. 
Strong applied statistical skills, including 
survival analysis, regression modeling, interim 
analyses, missing data strategies, longitudinal 
analyses, and other advanced statistical and 
clinical trial methods. PhD in Biostatistics or 
Statistics with at least 9 years of experience in 
analysis of data from clinical studies and design 
of clinical trials or other statistical 
experience in the life sciences. Experience in 
multiple clinical studies from the design through 
approval stages in the medical device or 
pharmaceutical industries. High level of 
knowledge of relational database function, and 
SAS Proc SQL. 


APPLICATION INSTRUCTIONS:
To apply, visit: www.medtronic.com/careers/ 
select requisition #69252 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.