Senior Biostatistician & Statistical Lead, Global Trials

MMS Holdings Inc; Manchester; Remote; GBP 70,000 - 110,000; Full time

Job summary

MMS Holdings Inc is a data-focused clinical research organization seeking a senior biostatistician to lead complex projects and regulatory submissions. The role emphasizes the application of biostatistical techniques across drug development, trial design, and CSR preparation.

You will collaborate with statisticians, programmers and medical writers, applying industry standards and providing analytical leadership for sponsorships and regulatory submissions.

Qualifications

• Masters in Biostatistics or related field; PhD preferred.
• 7+ years' experience in biostatistics or similar field.
• Submission experience (ISS/ISE).
• High level knowledge of drug development as it pertains to biostatistics.
• Excellent communication and teamwork skills.
• Excellent problem-solving skills.
• Familiarity with ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Experience with clinical trials and pharmaceutical development.

Responsibilities

• Lead complex projects, programs and submissions; manages client meetings and collaborates with regulatory, PMs and sponsors.
• Develop SAPs and iSAPs text and shells with minimal supervision.
• Prepare and present statistical methods and results sections for CSR in collaboration with medical writers.
• Provide statistical consulting support to sponsors on study design and sample size calculations.
• Review or create the statistical sections of a Sponsor’s protocol and ensure appropriate methods are proposed.
• Support DSMBs by preparing and presenting outputs as the unblinded statistician.
• Keep current with industry practices and updated regulatory guidelines.

Skills

Biostatistics

Statistical analysis

Project management

Communication

Regulatory knowledge

Data management

Education

Master's in Biostatistics

PhD preferred

Tools

SAS

R

Job description

MMS Holdings Inc is a data-focused clinical research organization seeking a senior biostatistician to lead complex projects and regulatory submissions. The role emphasizes the application of biostatistical techniques across drug development, trial design, and CSR preparation.

You will collaborate with statisticians, programmers and medical writers, applying industry standards and providing analytical leadership for sponsorships and regulatory submissions.