Senior Biostatistician Spain

hace 3 meses

Madrid, España Evidenze A tiempo completo

At **Evidenze** we are committed to the biomedical sector and healthcare professionals. We generate scientific evidence and transform it into knowledge to improve routine patient care for real transformation in the health sector.

With more than 300 employees, Evidenze offers a 360º service to the health sector from clinical research, patient support programs, medical training and communication and events.

For our **Biostatistics & Data Management department** we need to incorporate a proactive professional, eager to grow and work in a multidisciplinary team for the role of **Senior Biostatistician**. The position is hybrid and can combine teleworking and presence in our offices.

The professional will join a consolidated company within the field of clinical research and will be part of a work team with an excellent work environment, continuous training and great support from the managers and colleagues.

**Description of the tasks / routine work**:

- Providing statistical support to clinical studies,
- Participating in the development of study protocols, including participation in study design discussions and sample size calculations;
- Producing randomisation schedules;
- Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs);
- Performing statistical analyses;
- Interpreting statistical results;
- Strong communication skills;
**What We’re Looking For**:

- Master’s degree in mathematics, statistics or a related discipline. PhD strongly desired.
- 3+ years supporting clinical trial or RWE study in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP.
- Knowledge and implementation of advanced statistical methods.
- Good SAS programming skills.
- Strong knowledge of ICH guidelines.
- Knowledge of R programming a plus.
- Understanding & implementation of CDISC requirement for regulatory submissions is a plus.
- ADaM specifications generation and QC of datasets is a plus.
- Team player; willingness to go the extra distance to get results, meet deadlines, etc.
- Ability to be flexible when priorities change and deal with ambiguity.

**Language level**
- High English level

**Conditions**:

- Contract: Permanent full-time position
- Starting date: As soon as possible
- Flexible work schedule

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