Statistician

Validation Associates

Job Location:

Bethesda, MD - USA

Hourly Salary: $ 55 - 60

Posted on: 12 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description:

Collaborating with clinical investigators sponsor and cross-functional teams to determine study design;
Collaborating with Medical Writing and Project Management teams on protocol development including writing sections pertaining to statistical input;
Development of statistical analysis plans and programs to perform analyses and display study data;
Reviewing protocols and case report forms to ensure that protocol objectives are met and standards are maintained;
Generating treatment allocations in randomized clinical research studies and ensuring proper implementation;
Performing statistical analyses; writing and validating application programs including for centralized monitoring purposes;
Implementing data and safety monitoring reports to ensure participants safety;
Developing metrics and generating quality control reports to optimize the performance of clinical sites and the coordinating center;
Generating study reports to be distributed to internal and external monitoring committees and regulatory bodies;
Participating in professional development activities both within and outside the company
Other duties as assigned

Requirements:

Minimum of 3-5 years of experience in a CRO environment
Demonstrated proficiency with statistical methods and applications in clinical research.
Strong programming skills in SAS and/or R.
Ability to manage multiple tasks.
Ability to work independently as well as in a team environment.
Ability to effectively communicate technical concepts both written and oral

Compensation: $55.00 - $60.00 per hour

About Us

In a globally regulated life science industry Validation Associates provides proven methodologies in quality and compliance through hands-on practical solutions that ensure compliant effective and efficient quality systems. Since inception weve worked with the best in the life science and manufacturing industries and bring an intimate knowledge of regulatory and compliance standards.

Our services are built on a foundation of many years of experience in providing high standard well received and continually improved pharmaceutical validation training courses pharmaceutical consultancy pharmaceutical validation project management and pharmaceutical equipment verification / qualification and pharmaceutical process validation execution work.

Join our Team!

Validation Associates LLC takes pride in our capabilities to find and deliver the best people to our clients cultivate your skill set and find other opportunities that fits your needs and career path. We call on our top performers to help us close business make them Subject Matter Experts and help identify new growth. Our Engagement Leader Model is something we are proud of. Engagement Leaders are responsible for the onsite team of people at a given location helping each team member with their struggles and capitalizing on their strengths. Our proven success with this position is evident by the constant positive feedback we receive from hiring managers.

In addition to giving you the tools you need to excel including in-depth continuing education we inspire innovation and value new ideas encouraging you to apply creative concepts in achieving tangible results. We welcome your inquiries about the exciting opportunities available with us.

At Validation Associates LLC you will find an environment Where You and Your Career Can Thrive:

Validation Associates LLC offers employees compelling opportunities and rewards to match. Professional growth and thought leadership are the standard. And service quality and speed of performance are not weighted down with bureaucracy. Join our Team!!!

Required Experience:

Job Description:Collaborating with clinical investigators sponsor and cross-functional teams to determine study design;Collaborating with Medical Writing and Project Management teams on protocol development including writing sections pertaining to statistical input;Development of statistical analysi...

Job Description:

Collaborating with clinical investigators sponsor and cross-functional teams to determine study design;
Collaborating with Medical Writing and Project Management teams on protocol development including writing sections pertaining to statistical input;
Development of statistical analysis plans and programs to perform analyses and display study data;
Reviewing protocols and case report forms to ensure that protocol objectives are met and standards are maintained;
Generating treatment allocations in randomized clinical research studies and ensuring proper implementation;
Performing statistical analyses; writing and validating application programs including for centralized monitoring purposes;
Implementing data and safety monitoring reports to ensure participants safety;
Developing metrics and generating quality control reports to optimize the performance of clinical sites and the coordinating center;
Generating study reports to be distributed to internal and external monitoring committees and regulatory bodies;
Participating in professional development activities both within and outside the company
Other duties as assigned

Requirements:

Minimum of 3-5 years of experience in a CRO environment
Demonstrated proficiency with statistical methods and applications in clinical research.
Strong programming skills in SAS and/or R.
Ability to manage multiple tasks.
Ability to work independently as well as in a team environment.
Ability to effectively communicate technical concepts both written and oral

Compensation: $55.00 - $60.00 per hour