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2+ years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm/PhD 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

Job Description: Lead Statistician

Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office


Summarized Purpose

As a Lead Statistician, you will independently manage and carry out project statistician responsibilities with limited supervision. This includes developing analysis databases, conducting statistical analyses, generating formatted tables and summaries, and providing mentorship to junior team members.


Essential Functions

  • Compliance & SOPs: Ensure compliance with department SOPs and follow procedures for statistical analyses and programming.
  • Project Leadership: Lead a project team, conduct meetings, maintain project timelines, assess and provide resources, and prepare the project budget. Ensure SOP adherence and proper documentation.
  • Sponsor Interaction: Manage communication with the sponsor regarding all aspects of the project.
  • Team Collaboration: Work closely with programmers and data management teams to maintain and update databases. Guide others on database structures for analysis.
  • Sample Size Calculations & Protocol Review: Provide sample size calculations and review clinical protocols for completeness and appropriate statistical design.
  • Statistical Analysis Plan (SAP): Develop the SAP, including analysis database and table/listing specifications. Guide team members in implementing the plan.
  • Programming & Validation: Program and validate statistical tables, focusing on efficacy endpoints. Coordinate and ensure accuracy of documentation.
  • Report Reviews: Review reports, documents, and manuscripts, ensuring statistical methods are accurate and consistent.
  • Project Budget Monitoring: Monitor and communicate project budget, scope, and potential changes with management.
  • Department Support: Contribute to general department infrastructure, including presentations, teaching, policy development, and training new hires.

Education and Experience

  • Education: Master’s degree (or equivalent experience) in Statistics, Biostatistics, Mathematics, or a related field.
  • Experience:
    • Experience leading project teams, conducting team meetings, and maintaining project timelines and resources.
    • Experience with sample size calculations, protocol reviews, and randomization schemes.
    • Experience developing and implementing statistical analysis plans.

Knowledge, Skills, and Abilities

  • SAS® Programming Skills: Proficient in BASE, STAT, MACRO, and GRAPH; solid understanding of database structures.
  • Mentorship & Teamwork: Ability to mentor team members and promote collaboration within a multi-disciplinary setting.
  • Statistical Knowledge: Strong understanding of statistical principles and the ability to apply them effectively.
  • Project Management Skills: Experience in managing multiple projects, ensuring deadlines and budgets are met.
  • Communication Skills: Strong written and verbal communication skills in English.
  • Organizational Skills: Ability to manage competing priorities and adjust to changes effectively.
  • Positive Attitude: A collaborative mindset and the ability to work well with others.

This role offers a chance to work at the forefront of clinical trial analysis while leading a dynamic team, ensuring that statistical analysis is carried out effectively and within the required guidelines.