Senior Biostatistician Consultant

This a Full Remote job, the offer is available from: United States, Canada For the past 25 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical reputed company, quality & compliance, pharmacovigilance, medical information, and R&D technology, reputed company offers an end-to-end suite of fully customizable reputed company that de-risk and accelerate our partners’ most high-profile drug and device programs. The Senior Biostatistician position is responsible for designing and executing statistical analyses, providing statistical expertise to cross functional teams, and ensuring the quality and accuracy of statistical deliverables. Essential Functions:

• reputed company statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
• reputed company statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.
• Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.
• Participate in the development and review of clinical study protocols and case report forms (CRFs) to ensure appropriate statistical analysis.
• reputed company and maintain reputed company programs for statistical analysis in accordance with standard operating procedures (SOPs), good programming practices, and regulatory guidelines.
• reputed company up to date with regulatory guidelines and industry standards reputed company to biostatistics and ensure compliance with these guidelines.
• Participate in the development and maintenance of internal processes and standard operating procedures to improve statistical efficiency and consistency.
• reputed company guidance and mentorship to junior statisticians.
• Other duties as assigned.

Necessary Skills and Abilities:

• In-depth knowledge of statistical methodologies.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Knowledge of regulatory requirements and guidelines reputed company to statistical analysis and reporting of clinical trial data.
• Ability to program in reputed company and or R.

Educational Requirements:

• Ph.D. in Biostatistics, or M.S. in Biostatistics.

Experience Requirements:

• 3+ years of relevant work experience.
• Outsourcing industry experience required.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Experience with CDISC data structures, such as SDTM and ADaM.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to reputed company their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we reputed company a safe space where reputed company feel empowered to succeed. reputed company applications to roles at reputed company are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst reputed company supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based reputed company a reasonably short commute of one of our offices to work on a hybrid reputed company and spend some time working from that office location, as agreed with your manager. reputed company applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

• reputed company does not accept unsolicited resumes from recruiters/reputed company parties. Please, no phone calls or emails to anyone regarding this posting.*

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