About Pharm-Olam International:
Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach, then look no further, because Pharm-Olam International offers all of this and more. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary, and benefits package.
This individual is responsible for the efficient function of the Biostatistics department to ensure that deliverables of high quality are produced within the agreed upon timelines. Work with internal team members, senior management and business development on issues and questions of any biostatistical nature. Coordinate and manage the internal and external advisors and consultants to Pharm-Olam International. Ensure that statistical material, including tables, listings, graphs and statistical analysis plans produced by Pharm-Olam are appropriately reviewed and approved in accordance with Pharm-Olam's SOPs and GCP.
1. Plan and implement quality checks for clinical operations within the region
2. Lead operational activities of the Biostatistics Department
3. Evaluate workloads, resources, process, and technology for efficient operation of the department
4. Ensure systems are in place to produce quality work efficiently, allowing for continual growth of the department
5. Consult with project teams, sponsors, and FDA on project-related issues
6. Provide input to the statistical and programming portions of RFPs
7. Serve as a statistical consultant both inside and outside the company
8. Function as lead biostatistician on projects, as necessary
1. BA/BS in a Biostatistics, Master’s Degree in Biostatistics, preferred or a combination of education and experience.
2. A degree in biostatistics, or closely related field, with 7+ years or MS with 10+ years of experience.
3. Possess sufficient industry experience to be able to carry out duties and responsibilities of the position
4. Ability to lead in a multi-disciplinary team setting
5. Proven performance of required tasks, as evidenced by outstanding performance in current tasks and/or documented record of accomplishments
6. Evidence of strong management skills, as shown through management of multiple projects and staff members
7. Demonstrated initiative and motivation
8. Good organizational skills, with the ability to adapt and adjust to changing priorities
9. Positive attitude and the ability to work well with others
10. In-depth working knowledge of Phase I-IV clinical trials
11. Knowledge of regulatory requirements of clinical trials
12. Excellent written and verbal communication skills
13. Ability to communicate complex statistical concepts to non-statisticians
14. Ability to travel domestically and internationally as required.