Senior Biostatistician

MMS; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Biostatistician in Philadelphia. The role involves statistical analysis, project leadership, and collaboration with sponsor teams. Ideal candidates will have extensive experience in biostatistics and drug development, with strong communication skills and a graduate degree in a related field. Join a dynamic team focused on improving lives through innovative therapies.

Qualifications

• Minimum of 7 years' experience in biostatistics or a related field.
• Graduate degree preferred in Biostatistics, Statistics, or Mathematics.

Responsibilities

• Create randomization and kit schedules; develop phase 1-4 SAPs.
• Lead projects across all phases and manage smaller submissions.
• Support Data Safety Monitoring Boards by preparing output.

Skills

Statistical Analysis

Data Management

Communication

Problem Solving

Education

Biostatistics

Statistics

Mathematics

Tools

SAS

MS Office

Job description

MMS is an innovative data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory challenges. With a presence 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 extensive regulatory experience, helping our clients develop and market life-changing therapies to improve lives worldwide.

MMS values talented staff as the key to our success. We prioritize attracting top talent and providing ongoing training to enhance skills. At MMS, enthusiasm, collaboration, and teamwork are fostered, recognizing that a diverse, global talent pool strengthens our company. Follow MMS on LinkedIn for updates.

Responsibilities :

• Create randomization and kit schedules independently; collaborate with sponsor teams.
• Develop phase 1-4 SAPs and contribute to iSAPs. Create SAP TLF shells for all phases and studies.
• Review ADAM and TLFs; coordinate with clients and programmers to resolve comments.
• Apply strong programming and logic skills (working knowledge of SAS).
• Use drug development knowledge to produce high-quality statistical analyses.
• Perform sample size calculations for various scenarios and study designs.
• Lead projects across all phases and manage smaller submissions; coordinate with regulatory PMs and sponsors.
• Maintain strong knowledge of CDISC standards (SDTM, ADaM) and FDA guidance across therapeutic areas.
• Understand the tools we work with and possess high-level drug development knowledge related to biostatistics.
• Support Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Review statistical sections of sponsors' protocols; ensure appropriate methods; provide feedback; create statistical sections with minimal support.
• Proficient in MS Office applications.
• Understand project management tasks such as timelines, scope, and resource estimation.
• Provide ICH guideline-based input on statistics when applicable.
• Collaborate with medical writers to prepare and review statistical methods and results sections for CSR.

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 equivalent experience.
• Minimum of 7 years' experience in biostatistics or a related field.
• Expert knowledge of scientific principles and drug development processes.
• Thorough understanding of clinical data.
• Strong experience with data management and TLG production.
• Excellent scientific writing skills.
• Resourceful in biostatistics; willing to mentor others.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trials and pharmaceutical development preferred.
• Good communication and problem-solving skills.
• Organizational skills and familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CRO operations, scientific and clinical data, and drug development.

Required Experience :

Senior IC

Key Skills

Graduate degree in Engineering, Accounts, Building Materials, Customer Support, Horticulture, or related fields.

Employment Type : Full-Time

Experience : years

Vacancy : 1

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Biostatistician • Philadelphia, Pennsylvania, USA