Offer summary

Qualifications:

College graduate in Biostatistics, Statistics, or Mathematics; master's or PhD preferred., Minimum of 7 years’ experience in Biostatistics or a similar field required., Strong SAS programming skills and experience with clinical data., Excellent scientific writing and communication skills..

Key responsibilities:

Create randomization and kit schedules, collaborating with sponsors and management teams.

Develop and review statistical analysis plans (SAPs) and TLFs for various study phases.

Lead projects and manage client meetings, ensuring effective collaboration with regulatory teams.

Prepare and present statistical outputs for Data Safety Monitoring Boards (DSMB) and provide feedback on study protocols.

Job description

About MMS

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

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:

Experience in immunogenicity and serotype vaccine studies preferred
Experience in pediatric studies preferred
College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.
Minimum of 7 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.