FULL_TIME

FEED

YEAR

Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.

About MMSAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com" rel="nofollow">www.mmsholdings.com</a> or follow MMS on <a href="https://www.linkedin.com/company/mms-holdings-inc-" rel="nofollow">LinkedIn</a>.Senior Biostatistician:Responsibilities: <ul><li>Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.</li><li>Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.</li><li>Review ADAM and TLFs; work with client and programmers to resolve comments.</li><li>Strong programming and logic skills (working knowledge of SAS)</li><li>Ability to apply drug development knowledge during production of high quality statistical analyses.</li><li>Perform sample size calculations for a variety of scenarios and study designs.</li><li>Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.</li><li>Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas. </li><li>Understand the various tools that we work with</li><li>High level knowledge of drug development as it pertains to biostatistics.</li><li>Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.</li><li>Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support</li><li>High proficiency with MS Office applications</li><li>Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation.</li><li>Provide ICH guideline based input as applicable to statistics.</li><li>Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.</li></ul>Requirements:<ul><li>College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.</li><li>Minimum of 5 years’ experience in Biostatistics or similar field required.</li><li>Expert knowledge of scientific principles and concepts. </li><li>Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses.</li><li>Strong SAS programming, SAS base, SAS macro experience.</li><li>Thorough knowledge and understanding of clinical data preferred.</li><li>Strong experience with data and production of TLGs.</li><li>Excellent scientific writing skills.</li><li>Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.</li><li>Proficiency with MS Office applications.</li><li>Hands-on experience with clinical trial and pharmaceutical development preferred.</li><li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.</li><li>Excellent problem-solving skills.</li><li>Good organizational and communication skills.</li><li>Familiarity with 21 CFR Part 11, FDA, and GCP requirements.</li><li>Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.</li></ul>Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.Powered by JazzHR

Senior Biostatistician - Remote (US)

Accreditation Standards

Biostatistics

Biotech and Pharmaceutical

Clinical Data

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Research

Clinical Trial

Code of Federal Regulations

Communication Skills

Computer Programming

Contract Research Organization (CRO)

Customer Relationship Management (CRM) Systems

Customer Satisfaction

Drug Development

Employee Retention

FDA (Food and Drug Administration)

FDA Requirements

GCP (Good Clinical Practices)

ICH Regulations

LinkedIn

Mathematics

Medical Equipment

Medical Writing

Microsoft Office

Needs Assessment

Organizational Skills

Problem Solving Skills

Project Estimates

Project/Program Management

Regulations

Regulatory Submissions

Sales Management

Scientific Principles

Statistical Analysis System (SAS)

Statistics

Team Player

Vendor/Supplier Management

Wireless Multimedia Messaging Service

Writing Skills

partner JazzHR

OTHER

UNKNOWN

Develop and implement databases, data collection systems, data analytics, and other strategies that optimize statistical efficiency and quality while collaborating with other teams both inside and outside of the Finance organization to improve processes and cross functionally drive profitable growth. Whether you are looking to launch a new career in one of our many convenient Store locations, Distribution Centers, Store Support Center or with our Private Fleet Team, we are proud to provide a wide range of career opportunities.

Work Where You Matter:
At Dollar General, our mission is Serving Others! We value each and every one of our employees. Whether you are looking to launch a new career in one of our many convenient Store locations, Distribution Centers, Store Support Center or with our Private Fleet Team, we are proud to provide a wide range of career opportunities. We are not just a retail company; we are a company that values the unique strengths and perspectives that each individual brings. Your difference truly makes a difference at Dollar General. How would you like to Serve? Join the Dollar General Journey and see how your career can thrive.

Company Overview:
General Summary:The Licensing Analyst will be conducting a full licensing timeline and make recommendations to leadership regarding this process based on various performance analysis. While pushing to improve current efficiencies and growth, this role will collaborate with internal and external business partners to drive profitable growth.

Job Details:
Duties & Responsibilities:<ul><li>Develop and implement databases, data collection systems, data analytics, and other strategies that optimize statistical efficiency and quality while collaborating with other teams both inside and outside of the Finance organization to improve processes and cross functionally drive profitable growth. </li><li>Responsible for producing monthly, quarterly, and annual exception reports and licensing projections and collaborating with Tax Directors and Licensing Managers to compile and analyze licensing timeline data and translating analytical results to Director level leadership and below, making recommendations for improvements and applications of long-term solutions.</li><li>Assist Tax Director in generating and maintaining databases or other data collection resources to assist with compiling monthly, quarterly, and annual sales reports as directed.</li><li>Assists with other projects and tasks as directed.</li></ul>Knowledge, Skills and Abilities (KSAs):<ul><li>Ability to compose, analyze, and critically evaluate data to identify trends and suggest process improvements.</li><li>Excellent organizational, planning, and prioritizing skills needed to set and meet multiple deadlines and simultaneous tasks.</li><li>Possess excellent communication skills needed to build relationships with many stakeholders, both inside and outside of the Finance organization.</li><li>Advanced knowledge of Microsoft Office Suite with expert Excel skills.</li><li>Ability to work independently, as part of a group, and in gray areas to solve complex challenges.</li><li>Thinks strategically, possesses strong analytical capability, and has a solid business acumen.</li><li>Ability to work collaboratively across functional/organizational boundaries to leverage outcomes drive success.</li><li>Knowledge of complex database functions and ability to build multi user databases for business use</li></ul>

Qualifications:
Work Experience &/or Education:<ul><li>Bachelor Degree in business-related or quantitative field (Finance, Engineering, Statistics, Economics, or similar discipline). </li><li>Minimum of 1-2 years of experience in corporate business environment with knowledge of Accounts Payable, Forecasting, Budgeting, Database Management, or related fields. </li><li>Experience with licensing helpful.</li></ul>

Goodlettsville, Tenn.-based Dollar General Corporation is the nation's largest small-box discount retailer. We make shopping for everyday needs simpler and hassle-free by offering a carefully edited assortment of the most popular brands at low everyday prices in small, convenient locations. Dollar General ranks among the largest retailers of top-quality brands made by America's most-trusted manufacturers, such as Procter & Gamble, Kimberly Clark, Unilever, Kellogg's, General Mills and Nabisco. With more than $18 Billion in sales, Dollar General has over 12,000 stores in 43 states and 12 distribution centers.

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Senior Biostatistician - Remote (US) MMS

LICENSING ANALYST Dollar General

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