Senior Biostatistician - Remote

MMS Holdings Inc; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An innovative data-focused company is seeking a Biostatistician to support pharmaceutical and biotech industries. This role involves creating statistical analysis plans, performing sample size calculations, and leading projects while collaborating with clients and teams. With a commitment to high-quality service and technology solutions, the firm fosters a collaborative environment that values teamwork and continuous learning. If you have a strong background in biostatistics and a passion for improving lives through data, this opportunity is perfect for you.

Qualifications

• Minimum of 7 years’ experience in Biostatistics or similar field required.
• Expert knowledge of scientific principles and concepts.
• Experience in immunogenicity and serotype vaccine studies preferred.

Responsibilities

• Create randomization and kit schedules independently.
• Develop phase 1-4 SAPs and make significant contributions to iSAPs.
• Leads projects and manages client meetings.

Skills

SAS Programming

Statistical Analysis

Biostatistics

Scientific Writing

Problem Solving

Communication Skills

Education

Bachelor in Biostatistics

Master in Biostatistics

PhD in Biostatistics

Tools

MS Office

SAS Base

SAS Macro

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, visitwww.mmsholdings.comor follow MMS onLinkedIn.

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.