Senior Statistical Programmer

il y a 2 semaines

Paris, France Ergomed Temps plein

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

**The position is also available in any of our European locations**

**Job Description**:
The Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation. The Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps.

**Role and Responsibilities**
- Maintains responsibility for all assigned duties within a clinical study, this may include:

- Ensuring that work is performed on time
- Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality
- Leading complex or large studies with responsibility for all statistical programming activities and ensuring consistency across outputs and with any previous studies
- Works with other biometrics’ team members to represent the needs and input of the programming components of the study
- Create SDTM Specifications and program SDTM datasets from specifications
- Create ADaM specifications and program ADaM datasets from specifications
- Create CDISC submission packages e.g. Define.xml and Reviewers Guide
- Deliver training and mentorship to SP and other operational staff, as applicable
- Contribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related content
- File project-related BS documentation in the TMF
- Assist with Clinical Study Report (CSR) compilation
- Attend meetings with project team and/or client when needed
- Awareness of study budgets and progression. Identify out of scope work and proactively address or escalate budget issues
- Good knowledge and understanding of SAS Macro and ODS

**Qualifications**:
**Education**

Bachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science.
- Intermediate knowledge of SAS and statistical programming topics, including macros, relevant to clinical trials
- Thorough understanding of CDISC
- Understands general clinical trial conduct including GCP and ICH

**Experience**
- Minimum of 5 years’ of related experience, or equivalent combination of skills and education

**Special Skills**
- Organization skills, including attention to detail and multitasking
- Communication skills

**PC Skills**
- Knowledge of the MS Office Suite
- Proficiency in one or more statistical programming languages (includes SAS)

Additional Information
**The position is also available in any of our European locations**

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

LI Remote

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