Job Opening at Parexel

Job Summary
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.

Skills Required:

• Excellent analytical skills.
• Proficiency in SAS.
• Knowledge and understanding of the programming and reporting process.
• 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.

Knowledge and Experience:

• Minimum 18months statistical programming experience (preferably within clinical programming).
• Good communication skills.
• Competent in written and oral English.

Education:

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

Key Accountabilities:
Project Management:

• Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

Statistical Programming for Assigned Projects:

• Deliver best value and high quality service.
• Check own work in an ongoing way 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.

Training:

• 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.

General:

• 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).

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Job Purpose:

The Principal Clinical Data Engineer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Data Engineer will fill the lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required. Furthermore, the Principal Data Engineer will have an account oversight role within the function. General areas of responsibility also include: Aggregating applicable data from all sources and devices, managing external data, programming offline listings, trend analysis, understanding clinical data, data transfers. Furthermore, responsibilities will include developing standards and libraries (e.g. macros, templates or multi use-programs) to drive efficiencies within the group. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Key Accountabilities:

Manage electronic Data & Technology

• Lead and implement the setup of Data Receipt Agreements with vendors by working with cross functional teams.
• Programming and setup of Import procedures to allow the ingestion of data either using SAS or alternative technology (e.g. “Workbench”).
• Programming of reconciliation checks to ensure appropriate transfer of data.
• Programming of offline listings and custom reports to allow better insights to all external data.
• Aggrege data across all sources.
• Handling Missing Values, reading raw data files, creating data structures, handling programming errors, accessing, and managing data, appending and concatenating SAS datasets.
• Review of data using created outputs with aim of providing insights to study teams and clients.
• Coordinate and lead a programming team to successful completion of a study within given timelines and budget
• Manage the deployment of the DM technology used for creation of offline listings (e.g. Workbench, SAS or R). 
• Act as SME or technology owner on DM offline listing technology.

Support Projects   

• Assist in providing technical solutions to internal or external/client enquires.
• Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized.

Support Initiatives

• Participate in the creation of standards, either through tools (e.g. SAS Macros), libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.
• Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.

Act as a mentor and/or SME   

• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Assist in providing technical solutions to internal or external client enquires.

Ideal candidate will possess:

• SQL experience.
• Experience in ETL Programming environment (e.g. Oracle Workbench, Elluminate, SAS, Python, etc.).
• Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
• Strong experience in clinical research industry.
• Written and oral fluency in English.
• Bachelor’s degree in a relevant science discipline.
• Strong ability to lead and collaborate with global teams and work independently.  Motivate/guide virtual teams across multiple time zones and cultures to work effectively.
• Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach.
• Commitment to first time quality, including a methodical and accurate approach to work activities
• Proficient presentation skills.
• Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.

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Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

You will support Statistical Programming group in analyzing and reporting clinical trials.
Your tasks include:

• Producing datasets (for statistical analysis and regulatory submission purposes), statistical outputs such as statistical tables and graphs as well as data listings, utilizing SAS® Software.
• Learn about the pharmaceutical industry, what is involved in conducting a clinical trial and getting a new drug to market, as well as good clinical practices.

On your Parexel journey, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths. If you’re looking for flexibility and work-life balance, we’re here to listen and help you move forward with your individual career path. As a large multinational company, you may also work closely with colleagues in other locations such as Asia or North America. This is a great opportunity to develop skills and experience to help you during the final year of your degree course.

Qualifications:

• BSc/MSc student studying a degree in statistics, mathematics, computer sciences, computer and management studies.
• Knowledge of a statistic methods application such as SAS®, R, MATLAB, SPSS
• Ability to prioritize work and meet deadlines.
• Ability to work and communicate in a global project team environment.
• Self-motivated with a desire to develop and learn new skills.

Be part of our empowered Parexel Statistical Programming team and contribute to our patients first approach.

The deadline for application submissions is Friday 9th of June 2023! Please ensure you get your applications in by the above date!

Join our team in South Africa for a 6 month internship- where you will work with supervision to support various programming activities related to the analysis and reporting of clinical study data.

You will support Statistical Programming group in analyzing and reporting clinical trials.
Your tasks include:

• Producing datasets (for statistical analysis and regulatory submission purposes), statistical outputs such as statistical tables and graphs as well as data listings, utilizing SAS® Software.

• Learn about the pharmaceutical industry, what is involved in conducting a clinical trial and getting a new drug to market, as well as good clinical practices.

On your Parexel journey, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths. If you’re looking for flexibility and work-life balance, we’re here to listen and help you move forward with your individual career path. As a large multinational company, you may also work closely with colleagues in other locations such as Asia or North America. This is a great opportunity to develop skills and experience to help you during the final year of your degree course.

Qualifications:

• BSc/MSc student studying a degree in statistics, mathematics, computer sciences, computer and management studies.
• Knowledge of a statistic methods application such as SAS®, R, MATLAB, SPSS
• Ability to prioritize work and meet deadlines.
• Ability to work and communicate in a global project team environment.
• Self-motivated with a desire to develop and learn new skills.

Be part of our empowered Parexel Statistical Programming team and contribute to our patients first approach

Required Skills:

• Excellent analytical skills

• Knowledge of SAS

• Knowledge and understanding of the programming and reporting process.
• 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.
• 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.