Biostatistician II

CareAbout•Overland Park, KS

7d•$70,000 - $90,000

About The Position

The Biostatistician II is responsible for having a working 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.

Requirements

Bachelor's Degree or higher in Statistics or related field required.
Minimum of 2 Years of related experience preferred.
SAS, MS Word, Excel, Outlook, MS Teams, and Power Point.
Ability to read and interpret technical documents and industry specific manuals.
Ability to write advanced reports and correspondence.
Ability to speak effectively before groups of customers or employees of the organization.
Bilingual proficiency in French may be required, depending on location.
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 respect to work assignments and new learning.
Ability to prioritize workload.
Superior attention to detail.
Understanding of clinical research project life cycle and applicable regulatory guidelines.
Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to information technology (IT) systems as needed.
Moderate SAS programming proficiency.

Responsibilities

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.
Provide input for Biostatistics portion of project timelines.
Review of protocols for simple to complex studies.
Generate randomization schedules using SAS or randomization specific software.
Develop and quality control (QC) review statistical analysis for studies of simple to complex including those involving safety data and pharmacokinetic (PK) or pharmacodynamic (PD) endpoints.
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.
Development of tables of summary statistics and graphics for clinical aspects of clinical trials.
Assist in answering deficiency letters from regulatory agencies, as required.
Utilize SAS to create and validate inferential statistical programs and results.
Perform QC review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.
Oversee Preclinical projects and work with line manager to direct the activities of Biostatisticians on assigned projects which include reviewing the protocol, results of statistical analyses, statistical report produced by other Biostatisticians, and providing support across all statistical tasks during the lifecycle of the project from protocol to final report.
Coordinate with internal team to deliver high-quality documents in accordance with the timelines agreed upon.
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 participate or lead departmental or interdepartmental quality improvement initiatives.
Maintain and participate in the objectives of the department.
Other duties as assigned.