Lead Statistical Programmer - CRO

Posted 27 June 2024
Salary Negotiable
Job type Contract
Discipline CRO & Clinical Operations
Contact NameJames Aiton

Job description

Mantell Associates is partnered with a leading CRO dedicated to advancing healthcare through innovative research and development. They specialize in the field of oncology, striving to bring life-changing therapies to patients worldwide.

They are seeking a highly skilled and motivated Lead Statistical Programmer with extensive oncology experience to join their dynamic team on a contract basis.

Lead Statistical Programmer - Responsibilities:

  • Lead and manage statistical programming activities for oncology clinical trials, ensuring the delivery of high-quality, timely, and accurate programming deliverables

  • Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) for clinical trial reports

  • Collaborate with biostatisticians to ensure the accuracy and consistency of statistical analyses and outputs

  • Review and provide input on study protocols, statistical analysis plans (SAPs), and case report forms (CRFs) to ensure alignment with programming requirements

  • Ensure compliance with regulatory guidelines (e.g., FDA, EMA) and industry standards (e.g., CDISC) in all programming activities

  • Provide guidance and mentorship to junior programmers and other team members

  • Act as the primary point of contact for statistical programming-related queries and issues within the project team

  • Participate in the preparation and review of clinical study reports, regulatory submissions, and other clinical trial documentation

  • Stay current with developments in statistical programming and oncology research, and apply new knowledge to improve processes and deliverables

Lead Statistical Programmer - Requirements:

  • Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related field

  • Strong experience in statistical programming within the pharmaceutical or biotechnology industry, with a focus on oncology

  • Proficiency in SAS programming (Base SAS, SAS/STAT, SAS Macro Language)

  • Experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements

  • Strong understanding of clinical trial design, data analysis, and statistical methodologies

  • Excellent problem-solving skills and attention to detail

  • Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment

  • Proven ability to manage multiple projects and deadlines simultaneously

  • Experience with other programming languages (e.g., R) and software (e.g., JMP, Spotfire) is a plus

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.