Advanced Statistical Programmer

A well-organized and experienced Senior Statistical Programmer is required to lead statistical programming activities as Trial Programmer for several studies or as a Lead/Program Programmer for a medium to large-sized project in phase I to IV clinical studies.

1. Leads statistical programming teams to deliver high-quality outputs on time, ensuring the accuracy of statistical analysis results, compliance with company standards (e.g., CDISC), and adherence to regulatory requirements (e.g., GCP).
2. Coordinates activities of programmers internally or externally, makes statistical programming decisions, proposes strategies at study or project level, and ensures knowledge sharing among team members.
3. May act as functional manager for local associates, providing supervision and advice on functional expertise and processes.
4. Builds and maintains effective working relationships with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan).
5. Reviews eCRF, discusses data structures, reviews activities, ensures project-level standardization which allows pooling and efficient CRT production.
6. Complies with company, department, and industry standards, assesses and clarifies additional programming requirements, reviews, develops, and influences programming specifications as part of the analysis plans.
7. Provides and implements statistical programming solutions, acts as a programming expert in problem-solving aspects, and ensures timely and quality development and validation of datasets and outputs.
8. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
9. Maintains up-to-date advanced knowledge of programming software (e.g., SAS) as well as industry requirements (e.g., CDISC SDTM/ADaM, eCTD), attends functional meetings and trainings.
10. Establishes successful working relationships on individual studies with external associates according to agreed contract and internal business guidance.
11. Acts as subject matter expert (SME) or, as assigned, leads process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

Requirements:

• Education: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences, or related field.
• Languages: Fluent English (oral and written).
• Experience/Professional requirement:
  • Strong programming skills in R and Python and SAS. Demonstrated knowledge of data visualization, exploratory analysis.
  • Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications.
  • Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs.
  • Good understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, study procedures).
  • Proven communications and negotiation skills, ability to work well with others globally and influence.
  • Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project.
  • Ability to transfer own knowledge to others.
  • Ideal experience: 7+ years of work experience in a programming role preferably supporting clinical trials/or in pharmaceutical industry.
  • Experience in HTA/HEOR is preferable.
• Desired Skills:
  • Classification Systems
  • Clinical Trials
  • Computer Data Storage
  • Computer Programming
  • Cross-Functional Teams
  • Data Analysis
  • Data Structures
  • Initiative
  • Programming Languages
  • Reporting
  • Statistical Analysis