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Senior Biostatistician

3+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: PhD/MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Rewritten Job Description:

Position Title: Senior Biostatistician
Location: United Kingdom
Employment Type: Full-Time
Posted: 6 Days Ago
Job Requisition ID: JR 6539

About ProPharma:
For the past 20 years, ProPharma has been dedicated to improving patient health and wellness. As the world’s largest Research Consulting Organization (RCO), we partner with biotech, med device, and pharmaceutical companies to drive scientific breakthroughs and bring new therapies to market. With deep expertise across regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology, we offer end-to-end solutions to accelerate drug and device development.

Position Overview:
The Senior Biostatistician is responsible for leading statistical activities in clinical trials, including designing and executing statistical analyses. This role provides statistical expertise to cross-functional teams, ensuring that statistical deliverables meet the highest quality standards.

Key Responsibilities:

  • Lead statistical activities in clinical trials, including study design, statistical analysis plan development, and statistical analyses for FSP.
  • Offer statistical expertise to cross-functional teams such as clinical operations, data management, and regulatory affairs.
  • Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.
  • Contribute to the development and review of clinical study protocols and case report forms (CRFs) to ensure appropriate statistical analysis.
  • Develop and maintain SAS programs for statistical analysis, adhering to standard operating procedures (SOPs) and regulatory guidelines.
  • Stay updated on regulatory guidelines and industry standards to ensure compliance.
  • Assist in the development and improvement of internal processes and SOPs to enhance statistical efficiency and consistency.
  • Mentor and guide junior statisticians.
  • Perform other duties as assigned.

Required Skills & Qualifications:

  • Deep knowledge of statistical methodologies.
  • Strong communication and interpersonal skills to collaborate with cross-functional teams and external partners.
  • Excellent project management skills with the ability to manage multiple projects simultaneously.
  • Familiarity with regulatory guidelines related to statistical analysis and reporting in clinical trials.
  • Proficiency in SAS and/or R programming.
  • Ph.D. or M.S. in Biostatistics.
  • 3+ years of relevant experience, with experience in outsourcing industries required.
  • Expertise in clinical trial design, sample size calculations, and statistical analysis.
  • Experience with CDISC data structures, such as SDTM and ADaM.

Additional Information:
At ProPharma, we value diversity and strive to create an inclusive workplace where everyone can bring their authentic selves. We are committed to diversity, equity, and inclusion and encourage employees to be innovative and collaborative.


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