Remote, Senior Biostatistician, Biotechnology

MMS is a award-winning, data-focused clinical research organization (CRO). 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.

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Senior Biostatistician:

Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.

Strong programming and logic skills (working knowledge of SAS)

Ability to apply drug development knowledge during production of high quality statistical analyses.

Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.

Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.

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.

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 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.

Proficiency with MS Office applications.

Hands-on experience with clinical trial and pharmaceutical development preferred.

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 14days of your submission.