Principal Statistician

**Principal Statistician - Global CRO - Germany - Hybrid / Remote**

We have recently partnered with an award winning CRO, who are looking for an experienced Principal Statistician to join their successful study delivery team.

**The role**

The Principal Biostatistician will be accountable for the leadership of the Biostatistics activities of a collection of studies that are of high value to the organization. Also responsible for the activities of junior biostatisticians and programmers working on the assigned program of studies, ensuring studies are delivered on time, on budget and to required quality. Accountabilities also include maintenance of quality across studies.

**Desirable Experience**
- Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes
- Review project database structures
- Preparation of statistical analysis plans including the definition of derived data, and the design of statistical TFL's for clinical summary reports
- Statistical analysis, Interpretation of data and reporting of results
- Writing of the statistical methods sections of integrated study reports.
- Reviews draft integrated study reports.
- Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
- Participates in presentations at client and investigator meetings.
- Preparation of biostatistics input to company research proposals and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client.

**Key Qualifications and Skills**- M.S. or Ph.D. degree in statistics, biostatistics, or related field.
- Experience in statistics, biostatistics or related field in a CRO or Pharmaceutical environment
- Excellent verbal and written communication skills are required.
- SAS programming skills.
- Should be able to translate clients’ needs into statistical practice and educate clients in the use of statistics.
- In-depth knowledge of study designs, and statistical analysis conventions in one or more therapeutic areas.
- Knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must.

**What you get in return**

Ongoing development is vital, and as a Principal Biostatistician you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.
- In comparison with their competitor’s and pharmaceutical companies, they provide more flexible working platforms for coaching and educating newcomers to be highly respected professionals in our industry.

**Job Type**: Permanent

**Salary**: 60,000.00€ - 90,000.00€ per year

**Education**:

- Master's (preferred)