Biostatistician II

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Adhere to the standard operating procedures, forms, templates, and policies of the department and company.

• Serve as the Lead Biostatistician for a range of studies from simple to complex, acting as the main point of contact for assigned Biostatistics, internal project, and client teams.

• Contribute to the development of Biostatistics project timelines.

• Evaluate study protocols.

• Create randomization schedules using SAS or software specifically designed for randomization.

• Develop and ensure quality control for statistical analyses, including safety, pharmacokinetic, and pharmacodynamic endpoints.

• Create or assist in the development of Statistical Analysis Plans along with table, figure, and listing shells.

• Generate summary-statistics tables and graphics for clinical trials.

• Support responses to deficiency letters from regulatory agencies.

• Utilize SAS to develop and validate inferential statistical programs and their results.

• Conduct quality control reviews of analyses and documents produced by team members.

• Supervise preclinical projects and guide assigned Biostatisticians in collaboration with the line manager.

• Collaborate with internal teams to produce high-quality documents within deadlines.

• Represent Biostatistics during client and inter-departmental meetings.

• Execute work in accordance with SOPs, GCP, and regulatory standards.

• Stay informed about client and internal team expectations as well as relevant TPD, FDA, EMA, ICH, and GCP guidelines.

• Engage in or lead initiatives aimed at quality improvement.

• Contribute to and participate in departmental objectives.

• Undertake additional duties as assigned.

⛳️ Requirements

• A Bachelor's Degree or higher in Statistics or a related field is required.

• A minimum of 2 years of relevant experience is preferred.

• Proficient in SAS, MS Word, Excel, Outlook, MS Teams, and PowerPoint.

• Capability to read and interpret technical documents and industry-specific manuals.

• Proficient in writing advanced reports and correspondence.

• Ability to effectively communicate in front of groups of customers or employees within the organization.

• Bilingual proficiency in French may be required, depending on the location.

• Excellent verbal and written communication abilities.

• A professional demeanor along with strong interpersonal skills.

• Ability to collaborate effectively with a multidisciplinary team of professionals.

• A client-focused approach to tasks.

• Flexible attitude towards work assignments and eagerness to learn new concepts.

• Strong prioritization skills for managing workload.

• Exceptional attention to detail.

• Understanding of the clinical research project life cycle and relevant regulatory guidelines.

• Proficient computer skills (Microsoft Word, Excel, and PowerPoint) and ability to adapt to information technology systems as necessary.

• Moderate proficiency in SAS programming.

• Fluency in English is a mandatory requirement.

🏝️ 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