Biostatistician II

🔥 21 hours ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌪️ Kansas – Remote

🌪️ Kansas – Remote

💵 $70k - $90k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Altasciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2017-06

Healthcare • Consulting • Logistics

Altasciences is a forward-thinking, mid-size early phase contract research organization located in Canada and the U. S. , catering to biopharmaceutical companies of all sizes. The company specializes in offering a flexible approach to early drug development, with services that include preclinical safety testing, clinical pharmacology from Phase I to Phase II, bioanalysis from preclinical to Phase IV, as well as research and manufacturing analytical services. Altasciences is committed to accelerating early-phase drug development, ensuring seamless transitions from lead candidate selection to proof of concept and beyond, thereby delivering impactful results with a personal touch.

📋 Description

• Follow department and company standard operating procedures, forms, templates and policies. • Act as Lead Biostatistician for simple to complex studies and serve as the central point of contact for assigned Biostatistics, internal project and client teams. • Provide input for Biostatistics project timelines. • Review study protocols. • Generate randomization schedules using SAS or randomization-specific software. • Develop and quality-control statistical analyses, including safety, pharmacokinetic and pharmacodynamic endpoints. • Develop or assist with Statistical Analysis Plans and table, figure and listing shells. • Develop summary-statistics tables and graphics for clinical trials. • Assist with responses to regulatory-agency deficiency letters. • Use SAS to create and validate inferential statistical programs and results. • Perform QC reviews of analyses and documents prepared by team members. • Oversee preclinical projects and direct assigned Biostatisticians with the line manager. • Coordinate with internal teams to deliver high-quality documents on schedule. • Represent Biostatistics in client and inter-departmental meetings. • Conduct work in compliance with SOPs, GCP and regulatory guidelines. • Maintain awareness of client and internal team expectations and applicable TPD, FDA, EMA, ICH and GCP guidance. • Participate in or lead quality-improvement initiatives. • Maintain and participate in department objectives. • Perform other duties as assigned.

🎯 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. • Fluency in English is an essential 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