- Clinical Operations: Study Administration, Data Solutions, Monitoring, Clinical Safety, Study Solutions
- Evidence Generation: Surveillance Solutions (PACS), Scientific Solutions
- Operational Excellence
- Strategic Account Management
- Operations Support and Analytics
- Leads, manages, designs, develops, evaluates, and modifies programming initiatives to transform and analyze clinical data.
- Prepares specifications in collaboration with the Biostatistician
- Develops,validates and documents programming effort on analysis datasets, TLGs (Tables, Listings and Graphs) and Ad hoc Outputs based on Statistical Analysis Plans (SAP) and TLG shell specifications
- Codes proficiently in SAS and ensures all programming outputs pertaining to individual clinical studies meet required standards and are validated, correct, and maintained according to Statistical Programming Standards
- Proactively identifies data issues and assists in data cleaning by working with Statisticians & Data Managers to ensure clean clinical study data
- Writes, tests, documents, and validates studylevel and departmentlevel programs and macros
- Contributes to development of key studyrelated documents produced by other functions (e.g. CRF, Data Management Plan, Statistical Analysis Plan
- Represents the programming function as required, participates in cross functional team meetings; negotiates timelines and deliverables; takes ownership of projects, solves problems and works towards accomplishment
- Provides project management of all programming activities according to agreed resource and timeline plans
- Uses internal analysis macros to automate study deliverables
- Adheres to all the regulations, policies, SOPs, and other controlled documents
- Provides inputs to and participates in Programming and Clinical Data Science meetings
- Organizes own work priorities and handles multiple tasks simultaneously
- May Oversee the work of outsourcing partners and vendors at study level
- Mentors junior programmers and provides positive influence to ensure their work is in compliance with department goals and objectives
- Contributes to departmental standardization effort
- Performs other duties as directed by manager
- Recognizes inconsistencies and initiates resolution of data problems
- Implements data management plans designed to meet project and protocol deadlines, provides expertise in the design and development of clinical trials, protocols and case report forms
- Contributes in crossfunctional discussions and acts as liaison between clinical management, subcommittees, and project teams on an asneeded basis
- Bachelor's degree and 7+ years of statistical/programming (SAS) experience (or advanced degree and 5+ years)
- Experience with clinical trials data submission to regulatory agencies
- Bachelor's or Master's in Computer science
- 8+ years relevant experience in Statistics or related fields
- SAS programming experience at Medtronic or medical device industry
- Experience programming CDISC standards and electronic submissions.
- Knowledge of PL/SQL, Unix scripting, and R programing.
- Experience in leading and designing the implementation of departmental macros and utilities
- 2+ years of leading a therapy or multiple studies
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Principal Clinical IT Developer - Minneapolis, United States - Medtronic
Description
Careers that Change Lives
Position can be remote in the United States.
In this exciting role as the Prinicipal Clinical IT Developer (Statistical Programmer), you will be responsible for providing experienced, comprehensive, and advanced technical expertise as part of the centralized Biostats and Programming Operations (BPO) team in the Medtronic Clinical & Regulatory Solutions organization (MCRS).
You will be managing, planning and leading the development of solutions to all statistical analysis programming needs, particularly complex studies such as Premarket Approval (PMAs) studies.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.
We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
MCRS provides end-to-end clinical and scientific solutions for Medtronic including:A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Must Have:
Minimum Requirements
Nice to Have
About Medtronic
Together, we can change healthcare worldwide.
At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
For Office Roles:
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
(ADA-United States of America)_A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Learn more about our benefits_ here \_name=signon&co\_num=30601&co\_affid=medtronic) _.__This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6_ _here_ _._
_The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc._
Min Salary
$128000
Max Salary
$192000
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
Principal Clinical IT Developer professionals in Minneapolis
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Kelly Brabec
Clinical Documentation Integrity Advisor, RN