Senior Biostatistician

Senior Biostatistician (M/F/d)-230005GS

**Applicants are required to read, write, and speak the following languages***: English

**Preferred Qualifications**

Are you a Biostatistician who enjoys programming in SAS? If you have CDISC SDTM and ADaM experience, this is an incredible opportunity to excel in an exciting, fast-paced arena

Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre
- and post-drug launch activities. With more than 20 years’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements - empowering the Life Sciences industry to help improve patient outcomes.
- With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Oracle Life Sciences immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

The Senior Biostatistician provides advanced statistical input into the planning and development of clinical trials and non-interventional studies (NIS), performs analysis of study data, and gives statistical input for reporting of study results.

This role plays an integrated coordinating role in multi-disciplinary project and study teams. Further s/he ensures that all statistical operations comply with the respective SOPs and working instructions and further develops these. They will guides, coaches and develops junior members of the team and acts as a role model in this context. Additionally, the Senior Biostatistician may participate in business development tasks.

Qualifications:
6 years total combined related work experience and completed higher education, including:

- 1 year of Licensed health care practice, project/program management, process development/improvement and/or other clinical research work experience

Desired experience:

- Master’s or Bachelor's degree in Biostatistics or a related quantitative field preferred
- Several years of experience in Biostatistics consulting / statistical programming preferably within a CRO or a pharmaceutical company
- Advanced ability to program in SAS is a strongly preferred
- Ability to use SQL, Python, and other programming languages highly desirable.
- Good knowledge of regulatory standards and guidelines in clinical research are an advantage
- Sound knowledge of CDISC SDTM and ADaM standards are an advantage
- Knowledge and experience of working with medical and/or prescription claims data is desirable.
- Knowledge and experience of working with electronic health records (EHR) data is desirable.

What we will offer you
- A competitive salary with exciting benefits
- Learning and development opportunities to advance your career
- An Employee Assistance Program to support your mental health
- Employee resource groups that champion our diverse communities
- Core benefits such as life insurance, and access to retirement planning
- An inclusive culture that celebrates what makes you unique
- At Oracle, we don’t just respect differences—we celebrate them. We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities. That’s why we’re committed to creating a workplace where all kinds of people can do their best work. It’s when everyone’s voice is heard and valued that we’re inspired to go beyond what’s been done before._

**Detailed Description and Job Requirements**

Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

An experienced professional who is a domain and process expert with a deep understanding of research, clinical practices and solutions. Leads solution design for existing and prospective external customer engagements. Identifies areas for new solution offerings. Analyzes external customer needs and exercises judgment and business acumen in selecting methods and techniques to design non-routine and complex solutions to help ensure Oracle solution meets the customer’s objectives by combining industry best practices and program/process knowledge. Influences external customer leadership in acceptance of Oracle so