Manager Statistical Programming - Global Biopharma
Proclinical are recruiting for a Manager Statistical Programming - Global Biopharma to join a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Germany.
- You will await resource requirements and collaborate with management to guarantee adequate long-term resource delegation in a therapeutical project.
- Work alongside biostatistics to develop, execute and preserve suitable statistical applications, for example: data evaluation and reporting tools.
- Offer programming assistance to the regulatory proposals which involves data proposal package and define.xml development.
- The ideal candidate will cooperate with the clinical development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting.
- Conduct or monitor the production and/or validation of programming deliverables such as analysing datasets, tables, listings, etc, for study reports and integrated summaries.
- Other duties may be assigned.
Key Skills and Requirements:
- Proficiency in statistical programming which involves SAS/Base, Macro, STAT, GRAPH, SQL, etc.
- Comprehension of FDA, EMA, ICH and international guidelines and regulations.
- Expertise on industry standards suitable to clinical study data and reporting on clinical trials, which involves CDISC standards.
- Educated to a degree level in a statistics, mathematics, computer science or similar field though an danced degree would be ideal.
- Demonstrable experience working in a pharmaceutical, CRO or any other clinical research organisation.
- Familiarity with oncology or infectious disease therapeutic areas and proposals.
- Acquaintance with project management.
- An organised individual with a high attention to detail.
- Fluency in the English language.
- Communication skills both verbally and in writing.
- Capable of working within a fast-paced dynamic setting.
- Able to resolve issues and think analytically.
- Works well in a team.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on email@example.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.