Senior Statistician (Bloemfontein, SA based)

Senior Statistician (Bloemfontein, SA based)

Location: Bloemfontein, South Africa

Employment type: Full-time

We are looking for an enthusiastic and dynamic Statistician with demonstrable experience (typically built over several years) in biostatistical services to join our Team.

Your responsibilities

• Independently developing Statistical Analysis Plans (SAPs), including the definition of estimands, statistical analysis models and hypothesis tests, and the creation of mock shells.
• Coordinating the project team of statisticians and statistical programmers to ensure the quality and timelines of statistical deliverables such as SDTM, ADaM and TFLs.
• Performing quality control of datasets and TFLs, including the independent reprogramming of complex ADaM datasets and statistical analyses in SAS.
• Acting as the primary point of contact for our clients on all statistics-related questions.
• Supporting statistical consulting services for biotech and pharmaceutical clients, for example on study design, sample size calculation and protocol development, including estimands.
• Chairing Data Review Meetings (DRMs) and taking responsibility for decision-making and the corresponding documentation.
• Authoring or reviewing the statistical section of clinical trial reports (CTRs), and reviewing how the results are presented.
• Providing (I)DMC support as the independent statistician, accountable for the creation of (I)DMC reports and the hosting of (I)DMC meetings.
• Managing the budgets of your assigned projects, including the preparation of performance reports and the initiation of change orders.
• Taking part in Bid Defence Meetings and presenting our biostatistical services, including statistical programming.
• Representing Metronomia's biostatistics team in regulatory inspections and customer audits.

Your profile

• A university degree in statistics, mathematics, mathematical biometrics or a comparable qualification.
• At least three years' professional experience as a statistician at a CRO or in the pharmaceutical industry, with previous project responsibility.
• Very good knowledge of the relevant regulatory guidelines and CDISC standards.
• Excellent communication and interpersonal skills, and a genuine enjoyment of working closely with clients.

What we offer

• Recognition and a family-friendly culture: hybrid working models and a workplace that values you as a person.
• Reward that reflects your contribution: competitive remuneration and a comprehensive benefits package.
• Health and wellbeing: a benefits package designed to support your health.
• Flat hierarchies: we work together as equals to build a motivated, high-quality team.
• Engaging work: a thorough onboarding and regular opportunities for internal and external training and development.

Have we piqued your interest? We look forward to getting to know you!

Upload your Cover Letter and CV or LinkedIn profile, including potential start date and compensation expectations via our career page. If you have any questions in advance don't hesitate to contact our HR Managers Lachaé Leo (***email_hidden***) or Christoph Hortian ([email protected]).

Metronomia Clinical Research - www.metronomia.net

Since 1990, METRONOMIA has stood for quality, competence, continuity and unconditional customer orientation in terms of data management, statistical services and medical writing in clinical research. As a growth oriented medium sized company with over 155 employees, we operate internationally. Our customers appreciate the competence and commitment of our employees, and we value our employees as the basis of the company's success.

Metronomia is an equal opportunities employer. We welcome applications from all suitably qualified candidates and are committed to a fair and inclusive recruitment process. If you require any reasonable adjustments at any stage, please let us know.