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Statistical Programmer II (Clinical SAS Programmer), South Africa

Statistical Programmer II (Clinical SAS Programmer), South Africa

ParexelSouth Africa
30+ days ago
Job description

Statistical Programmer II (Clinical SAS Programmer), South Africa

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

Overview

Role overview and context of responsibilities as described in the job posting.

Responsibilities

  • Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
  • Deliver best value and high quality service for Statistical Programming on assigned projects.
  • Check own work to ensure first-time quality; use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
  • Assist in the production / QC of derived dataset specifications and other process supporting documents and submission documentation.
  • Maintain and expand local and international regulatory knowledge within the clinical industry.
  • Develop knowledge of SAS and processes / procedures within other Parexel functional areas.
  • Provide relevant training and mentorship to staff and project teams as appropriate.
  • Maintain all supporting documentation for studies in accordance with SOPs / Guidelines to ensure traceability and regulatory compliance.
  • Ensure compliance with SOPs / Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal / external audits and regulatory inspections as required.
  • Proactively participate in process / quality improvement initiatives.
  • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Qualifications

  • Excellent analytical skills.
  • Proficiency in SAS with solid knowledge and understanding of the programming and reporting process. A minimum of 1.5 years Clinical (SAS) Programming experience is required.
  • Knowledge of SOPs / Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
  • Ability to learn new systems and function in an evolving technical environment.
  • Ability to manage competing priorities and flexibility to change.
  • Attention to detail.
  • Ability to successfully work as part of a global team.
  • Work effectively in a quality-focused environment.
  • Effective time management in order to meet daily metrics or team objectives.
  • Show commitment to and perform consistently high-quality work.
  • Business / operational skills that include customer focus, commitment to quality management, and problem solving.
  • Competent in written and oral English.
  • Good communication skills.

    • Education

  • Educated to degree level in a relevant discipline and / or equivalent work experience.

    • Key Accountabilities / Role Details

  • Accountability : Project Management; Activities : Coordination of project start-up activities, global program creation, tracking spreadsheets, and required documentation.
  • Statistical Programming for Assigned Projects : Deliver value and high-quality service; check own work for first-time quality; use efficient techniques to produce SDTM / ADaM datasets, tables, figures, and listings; QC derived datasets and submission materials.
  • Training : Maintain regulatory knowledge, develop SAS knowledge, provide training and mentorship.
  • General : Maintain documentation for studies per SOPs / Guidelines; ensure regulatory compliance; participate in audits and inspections; participate in process / quality improvement; understand regulatory requirements for industry standards (CDISC, 21 CFR Part 11, electronic submissions).

    • Seniority level

  • Entry level

    • Employment type

  • Full-time

    • Job function

  • Science, Analyst, and Information Technology

    • Industries

  • Pharmaceutical Manufacturing
  • Biotechnology Research
  • Hospitals and Health Care

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    Clinical Programmer • South Africa