Biostatistician II

Overland Park, Kansas, United States
Remote
Posted Oct 9, 2026
1 position

US$70,000–US$90,000 / year

Opens an external site

Employment type: Full-time
Experience level: Mid-level · 2+ years
Minimum education: Bachelor’s degree
Posting language: English
Working hours: 40 hours per week

Job summary

The Biostatistician II acts as the lead for clinical studies, managing the biostatistics team and ensuring all analysis and documentation comply with regulatory standards. They are responsible for developing statistical analysis plans, generating randomization schedules, and overseeing the quality control of clinical trial data.

Job details

About The Role 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. 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. 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. What You'll Need to Succeed 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. Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Biostatistician II including, but not limited to, for the following reasons: The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies. The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices. What We Offer The salary range estimated for this position is $70,000 - $90,000. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. Altasciences’ Benefits Package Includes: Health/Dental/Vision Insurance Plans 401(k)/RRSP with Employer Match Paid Vacation and Holidays Paid Sick and Bereavement Leave Employee Assistance & Telehealth Programs Altasciences’ Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program Annual Performance Review #LI-JG1

What you’ll do

Requirements

Candidates must hold at least a Bachelor's degree in Statistics or a related field with a minimum of 2 years of relevant experience. Proficiency in SAS programming and a strong understanding of clinical research project lifecycles and regulatory guidelines are required.