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Remote Cdisc Jobs in Michigan (NOW HIRING)

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Remote Cdisc information

What is the difference between Remote Cdisc vs Remote Data Analyst?

AspectRemote CdiscRemote Data Analyst
Required CertificationsCDISC certifications, knowledge of CDISC standardsTypically a degree in data science, statistics, or related field; certifications vary
Work EnvironmentPharmaceutical/clinical research companies, CROs, remoteVarious industries including healthcare, finance, tech; remote options common
Industry UsagePrimarily in clinical research and pharmaceutical sectorsAcross multiple sectors including healthcare, finance, marketing
Common Search/ComparisonYesYes

Remote Cdisc specialists focus on clinical data standards and regulatory compliance within the pharmaceutical industry, often requiring CDISC certifications. Remote Data Analysts have broader roles across industries, analyzing data sets with varying tools and certifications. While both roles involve data handling, Remote Cdisc professionals specialize in clinical data standards, making their skills more industry-specific compared to the versatile role of Remote Data Analysts.

What are the key skills and qualifications needed to thrive as a remote CDISC specialist?

To excel as a Remote CDISC Specialist, you need expertise in clinical data management, a thorough understanding of CDISC standards (such as SDTM and ADaM), and a relevant degree in life sciences or a related field. Proficiency with tools like SAS, Pinnacle 21, and clinical trial management systems, along with CDISC certification, is highly valued. Strong attention to detail, effective communication, and problem-solving abilities are crucial soft skills for this remote role. These competencies ensure accurate, compliant clinical data submissions and effective collaboration across distributed teams in regulatory environments.

What is a remote CDISC professional?

A Remote CDISC professional is someone who works remotely to implement and manage data standards set by the Clinical Data Interchange Standards Consortium (CDISC) in clinical research. Their role typically involves converting, validating, and submitting clinical trial data to regulatory authorities in accordance with CDISC models, such as SDTM and ADaM. Remote CDISC professionals often collaborate with data managers, statisticians, and programmers to ensure data quality and compliance, utilizing specialized software and tools. Working remotely allows them to perform these tasks from any location, provided they have secure internet access and the necessary technical setup.

What are some common challenges faced when working remotely as a CDISC specialist, and how can they be addressed?

As a remote CDISC specialist, one of the most common challenges is maintaining clear communication with clinical data teams and stakeholders across different time zones. Ensuring data standards compliance and timely submissions can also be complex without face-to-face collaboration. To address these challenges, it's important to set regular video meetings, use collaborative project management tools, and document processes clearly. Building strong virtual relationships and proactively seeking feedback can help ensure data integrity and project alignment.
What are popular job titles related to Remote Cdisc jobs in Michigan? For Remote Cdisc jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Remote Cdisc jobs in Michigan look for? The top searched job categories for Remote Cdisc jobs in Michigan are:
Remote Cdisc jobs near you

Senior Biostatistician - Remote (US)

MMS Holdings Inc.

Canton, MI • On-site, Remote

Full-time

Re-posted 23 days ago

Job description

About MMS
Are 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 www.mmsholdings.com or follow MMS on LinkedIn.
Senior Biostatistician:
Responsibilities:
  • Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.
  • Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.
  • Review ADAM and TLFs; work with client and programmers to resolve comments.
  • Strong programming and logic skills (working knowledge of SAS)
  • Ability to apply drug development knowledge during production of high quality statistical analyses.
  • Perform sample size calculations for a variety of scenarios and study designs.
  • Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.
  • Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas.
  • Understand the various tools that we work with
  • High level knowledge of drug development as it pertains to biostatistics.
  • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
  • 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
  • High proficiency with MS Office applications
  • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation.
  • Provide ICH guideline based input as applicable to statistics.
  • Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.
Requirements:
  • College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.
  • Minimum of 5 years' experience in Biostatistics or similar field required.
  • Expert knowledge of scientific principles and concepts.
  • 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.
  • Strong SAS programming, SAS base, SAS macro experience.
  • Thorough knowledge and understanding of clinical data preferred.
  • Strong experience with data and production of TLGs.
  • Excellent scientific writing skills.
  • Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • Good communication skills and willingness to work with others to clearly understand needs and solve problems.
  • Excellent problem-solving skills.
  • Good organizational and communication skills.
  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
  • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

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