Senior Biostatistician

By clicking the Accept button, you agree to us doing so.

Learn more:

Senior Biostatistician page is loaded## Senior Biostatistician remote type:
Remote locations:
Overland Park, Kansas time type:
Full time posted on:
Posted Yesterday job requisition :
R102278
** Your New Company!
** At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team!

Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future  are better together and together We Are Altasciences.
** About

The Role
** The Senior Biostatistician is responsible for having expert knowledge of all related processes with the ability to independently lead a study, support analysis, and provide high-quality documents to support sponsors' research programs, , and deliver a high level of quality and timeliness, resulting in high levels of client satisfaction.
** What You’ll Do Here*
* • Follow department and company standard operating procedures (SOPs), forms, templates and policies.  
• Act as Lead Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team and the client.  
• Mentor, guide, and train other Biostatisticians in all aspects of the Lead Biostatistician role and all other tasks.  
• Provide input for Biostatistics portion of project timelines.  
• Review and provide statistical guidance for protocols for simple to complex studies.  
• Create and provide Biostatistics-related training to create and sustain culture of continuous improvement.  
• Generate randomization schedules using SAS or randomization-specific software.  
• Develop and quality control (QC) review statistical analysis for simple to complex studies.  
• Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells for studies of simple to moderate complexity.  
• Develop tables of summary statistics and graphics for clinical aspects of clinical trials.
• Develop Inferential Statistics.
• Potentially support some Statistical Analysis for our Preclinical group.
• Provide statistical analysis for PD subjective measures and PK endpoints.  
• Responsible for answering deficiency letters from regulatory agencies, as required.  
• Validate Biostatistician programs and results using SAS.  
• Perform QC review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.  
• Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.  
• May represent Biostatistics in client and inter-departmental meetings.  
• Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines.  
• Maintain familiarity with client and internal team expectations and produce analyses and documents consistent with these.  
• Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], FDA, European Medicines Agency [EMA], etc) as well as ICH and GCP procedures.  
• May lead or participate in departmental or interdepartmental quality improvement initiatives.  
• Maintain and participate in the objectives of the department.  
• Oversee direct reports as assigned.
** What You’ll Need to Succeed*
* • Bachelor's Degree or higher in Statistics or related field. Masters in Statistics is preferred.  
• Excellent verbal and written communication skills.  
• Professional attitude and strong interpersonal skills.  
• Ability to work well with a multi-disciplinary team of professionals.  
• Client-focused approach to work.  
• Flexible attitude with…