Senior Backend Engineer — C#/.Net & C++ (Remote)

Deviare; South Africa; Remote; ZAR 900,000 - 1,200,000; Full time

Job summary

Parexel is seeking a Senior Statistical Programmer (FSP) to join our team in South Africa, dedicated to a single sponsor.

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data.

Qualifications

• Educated to degree level in a relevant discipline or equivalent work experience.
• Competent in written and oral English.
• Knowledge of ICH-GCP, SOPs and regulatory inspections including 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Strong attention to detail and accuracy in programming outputs.

Responsibilities

• Provide technical expertise for the conduct of clinical trials.
• Lead statistical programming timelines and coordinate a team on projects.
• Review SAPs and database set-up specifications.
• Interact with sponsors and internal stakeholders on programming issues.
• Maintain supporting documentation per SOPs and guidelines to ensure traceability and compliance.

Skills

Excellent analytical skills

Programming & reporting process

ICH-GCP & 21 CFR Part 11

Global team collaboration

Time management

Attention to detail

Learning new systems

Education

Degree in a relevant discipline

Job description

Key Accountabilities

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 low-medium complexity derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.

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.

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.

Skills

• Excellent analytical skills.


• 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.

Knowledge and Experience

• Competent in written and oral English.


• Good communication skills.

Education

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

#LI-REMOTE

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Senior Statistical Programmer (FSP) - South Africa

At Parexel FSP people make a difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.

Parexel is currently seeking a Senior Statistical Programmer to join us in South Africa, dedicated to a single sponsor.

Picture Yourself At Parexel: The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data.

Project Management

• Ability to fill Statistical Programming Lead role on projects.


• Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.


• Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.


• Monitor project resourcing, project budgets, and identify changes in scope.


• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.


• Review statistical analysis plans and mock-shells.


• Review database set-up specifications.


• Interact with sponsors and internal stakeholders with regard to statistical programming issues.


• Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Statistical Programming for Assigned Projects

• Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM/TLF), tables, figures, and data listings.