Altasciences · 7 hours ago
Senior Biostatistician- FR
Overland Park, KS
Full-time
Onsite
Mid, Senior Level
$80K/yr - $110K/yrAltasciences is dedicated to the discovery, development, and manufacturing of new drug therapies. The Senior Biostatistician will lead studies, provide statistical analysis, and ensure high-quality documentation to support research programs, maintaining high levels of client satisfaction.
BiotechnologyHealth CareMedical
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
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
Qualification
Required
Bachelor's Degree or higher in Statistics or related field
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
Excellent SAS programming proficiency
Preferred
Masters in Statistics is preferred
Benefits
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Training & Development Programs
Employee Referral Bonus Program
Annual Performance Review
Company
Altasciences
Outsourcing made easy with a one-stop solution to early-phase drug development.
Founded in 1992
1001-5000 employees
H1B Sponsorship
Altasciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
Beatrice S.
Chief Scientific Officer
Bryce Linna
HR Business Partner
Company data provided by crunchbase