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25 days old

Sr. Biostatistician/Statistics Manager

Kelly Services
Deerfield, IL 60015
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.


Kelly Science & Clinical is seeking a Statistics Manager/Sr. Biostatistician to join their team remotely for an American multinational health care company that primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions. For immediate consideration, please email your resume directly to: Regan.Brown@KellyServices.com as well as apply online.


**Statistics Manager**


**~4 Months (contract W2)**

**Pay Rate: BOE/TBD**


Description:


Job Title: Statistics Manager

Department: Strategy & Delivery

Function: Statistics

Location: Remote


Essential Duties & Responsibilities:


+ Responsible for taking an active role in defining the strategy for projects including recommendation of appropriate research design, definition of patient population, measurement of outcome variables, and hypothesis development.

+ Author and provide input on relevant sections of research protocols including endpoint specification, study logistics, sample size determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).

+ Manage Contract Research Organization (CRO) statistics activities as needed.Participate and assist in the development and approval of global statistics strategies in collaboration with colleagues.

+ Attend investigator and coordinator meetings, representing the statistics group.

+ Manage data release and review meetings for clinical projects; reviews and participates in finalizing and obtaining approval of final manuscript or final reports for projects.

+ Provide support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority advisory panels.


Qualifications:


+ Expert knowledge of SAS software and general computing in the medical device / pharmaceutical area as it relates to clinical trials in research and development.

+ Strong working knowledge of statistical data analysis and data management principles.

+ Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical medical device business.

+ Ability to lead and contribute to cross functional teams consisting of statisticians, data managers, clinicians and computer programmers on drug development projects resulting in successful worldwide regulatory filings, product launches and approvals.

+ Ability to communicate ideas and energize others to accomplish challenging goals and objectives.

+ Ability to work with clinical professionals within a team, as well as working in a cross-functional product development setting.

+ Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports.

+ Ability to manage multiple priorities and clients while maintaining performance.

+ Knowledge of pharmaceutical quality and regulatory requirements.

+ Ability to lead, mentor, and develop others.

+ Good organizational skills and excellent written and verbal communication skills.


Education and/or Experience:


+ Masters or PhD in Statistics or related area is required.

+ A minimum of at least 5-7 years of related medical device industry experience (pharma is okay, but device preferred).

+ Experience with SAS required, PASS (sample size software) would be a plus, they should know at least one sample size software if not PASS.


**Why Kelly:**


+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies.

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career.

+ Access to more than 3,000 online training courses through our Kelly Learning Center, including accredited courses to obtain IT certifications, as well as PDU-approved courses.

+ Weekly pay.

+ Group-rate insurance options available immediately upon hire.*


**Apply today!**


**Refer a friend!**


*Available for purchase and administered by a designated third-party vendor. (80)


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-21 Expires: 2021-06-28

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Sr. Biostatistician/Statistics Manager

Kelly Services
Deerfield, IL 60015

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