Senior Biostatistician - Remote

MMS; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Mid-Senior level Biostatistician. The role involves creating randomization schedules, developing statistical analysis plans, and leading projects. The ideal candidate will have extensive experience in biostatistics, strong SAS programming skills, and a solid understanding of drug development processes. This position offers the opportunity to work on impactful projects that contribute to life-changing therapies.

Qualifications

• Minimum of 7 years’ experience in Biostatistics or similar field.
• Expert knowledge of scientific principles and concepts.
• Strong SAS programming skills, including SAS base and macro.

Responsibilities

• Create randomization and kit schedules independently.
• Develop phase 1-4 SAPs and contribute to iSAPs.
• Lead projects and manage client meetings.

Skills

SAS

Biostatistics

Statistical Analysis

Communication

Organizational Skills

Education

College degree in Biostatistics

Master's or PhD in related field

Tools

MS Office

Job description

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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 contribute to iSAPs. Create SAP TLF shells for all phases and studies.
• Review ADAM and TLFs; work with clients and programmers to resolve comments.
• Apply strong programming and logic skills (working knowledge of SAS).
• Utilize drug development knowledge during the production of high-quality statistical analyses.
• Perform sample size calculations for various scenarios and study designs.
• Lead projects (all phases and study programs) and smaller submissions, manage client meetings, CRMs, and collaborate with regulatory teams, PMs, and sponsors.
• Maintain strong knowledge of CDISC standards (especially SDTM and ADaM), and interpret FDA guidance across therapeutic areas.
• Understand the various tools used in the work environment.
• Have a high-level knowledge of drug development as it relates to biostatistics.
• Support Data Safety Monitoring Boards (DSMB) by preparing and presenting unblinded statistical outputs.
• Review the statistical section of Sponsor protocols to ensure appropriate methods are proposed; provide feedback and create statistical sections with minimal support.
• Proficient in MS Office applications.
• Understand project management tasks such as timelines, scope, and resource estimation.
• Provide input based on ICH guidelines as applicable.
• Prepare and review statistical methods and results sections for CSR in collaboration with medical writers.

Requirements

• Experience in immunogenicity and serotype vaccine studies preferred.
• Experience in pediatric studies preferred.
• College degree in Biostatistics, Statistics, Mathematics, or related field; master's or PhD preferred, or extensive related experience.
• Minimum of 7 years’ experience in Biostatistics or similar field.
• Expert knowledge of scientific principles and concepts.
• High-level knowledge of drug development as it pertains to biostatistics; ability to produce high-quality analyses.
• Strong SAS programming skills, including SAS base and macro.
• Thorough understanding of clinical data preferred.
• Experience with data and production of TLGs.
• Excellent scientific writing skills.
• Resourceful in biostatistics; willing to guide others in techniques.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trials and pharmaceutical development preferred.
• Good communication skills; team-oriented problem solver.
• Strong organizational skills.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CRO operations and clinical data/terminology, and drug development process.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing