Rtsm Biostatistician

If you're passionate about translating data into actionable insights and ready to impact lives, we want to hear from you.

**Responsibilities**

**Product and Customer Design Services**: Consult with product, engineering and customers to understand statistical needs. Provides input to the product roadmap. May consult with customers regarding randomization methods and design.

**Collaboration**: Collaborate with project teams to address complex questions and solve practical problems to deliver on time, with high quality, and within budget. Participates in effective customer relationships, owns statistical discussions and provides support and guidance for statistical activities. Document where necessary and follow up on actions. Actively attend internal project team meetings and provide timely progress updates.

**Study Testing and Validation**: Defines standards and test strategies for randomization validation according to Standard Operating Procedures (SOPs). Reviews validation results and confirms test scope and accuracy.

**Randomization and Quality Monitoring**: Overseeing live study randomization checks and evaluates clinical trial data as appropriate. May support sponsors as needed with data analysis.

**Randomization List Management**: Owns the process for the generation of randomization and kit lists and associated specifications to meet study design protocol requirements; using Ultima Rand, 4G’s product for list generation.

**Required Experience**
- SAS or R programming skills required, SAS certified preferred.
- Competent programming skills preferred.
- Excellent written and oral communication skills, including grammatical/technical writing skills.
- Excellent focus on details and accuracy.
- In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

**Education and/or Certificate Requirements**

A PhD Degree in Statistics/Biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master’s degree with a minimum of 9 years relevant work experience.

4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels. 4G Clinical came in at #8 for its dedication to building a culture that fuels innovation, curiosity, and the spirit of experimentation in all facets of the business from product development and brand to services and staffing. We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE.

**_ We offer compelling benefits to our international and US-based employees. Benefits vary by region and should be discussed with a 4G Talent Acquisition or HR representative._**
- 4G Clinical is proud to be an Equal Opportunity Employer, and it is foundational to how we recruit and hire our talented team. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law._