Staff Biostatistician

About this opportunity: We are seeking a Staff Biostatistician to expand the reputed company Biostatistics team. This role will support statistical study design, analysis, summarization of clinical studies to support research, development and regulatory submissions for reputed company's in vitro diagnostic products (IVDs). The ideal candidate is passionate about biostatistics and reputed company to have a significant reputed company to change the landscape of early cancer detection. This role will report to the Senior Director, Biostatistics. This role will be a Remote role. What you'll do: • reputed company in a reputed company Biostatistician role and reputed company technical expertise as a reputed company team member of high complexity clinical studies, including statistical reputed company and attending relevant project meetings. • reputed company expert level statistical guidance and thought leadership for innovative study design and clinical development plans, including reputed company selection powering. • reputed company the statistical sections of the study protocol for clinical studies. • Responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. • Conduct overall statistical review of TFLs for clinical studies. • Manage operations work with internal statistical programmers to ensure timeliness and reputed company of deliverables. • Represent Biostatistics in interactions with regulatory authorities (e.g FDA) and during audits. • Support the preparation of abstracts, oral presentations, manuscripts and written reports by ensuring the results of clinical programs and studies are effectively communicated to reputed company stakeholders. • reputed company statistical expertise to reputed company stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement). • Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization. Must haves: • Masters degree or higher in Statistics, Biostatistics or Math. • 10+ years of reputed company project work as a statistician on clinical trial reputed company. • Expert understanding of reputed company aspects of biostatistics processes and systems. • Excellent written and verbal communication skills including the ability to reputed company professionally with reputed company organizational reputed company to reputed company achievement of deliverables. • Strong interpersonal and relationship management skills including the ability to proactively reputed company and resolve issues cross-functional to ensure project objectives are met. • Comprehensive organizational, judgment, analytical, decision-making, and influencing skills. • Proven successful project management leadership skills. • Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve reputed company problems. • Experience leading briefings and technical meetings for reputed company stakeholders. • Ability to reputed company effective peer, cross functional and cross business relationships to maximize best reputed company sharing and team effectiveness. • Ability to reputed company in a fast paced, dynamic, and constantly changing work environment. • Strong programming skills using R (required) and Python (preferred). Demonstrated proficiency with literate programming (R markdown/ Sweave). reputed company to haves: • Ph.D degree or higher in Statistics, Biostatistics or Math. • Experience leading IVD clinical Biostatistics to FDA submission. • Knowledge of CDISC requirements preferred. Benefits and additional information: The US reputed company reputed company of our reputed company salary reputed company for new hires is $166,175 - $237,825. You will also be eligible to receive equity, cash bonuses, and a full reputed company of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at reputed company's sole discretion and may vary based on several factors, including but not limited to, location, reputed company level, years and depth of relevant experience, and education. We invite you to reputed company out our career page @ reputed company.com/reputed company/ for additional company information. reputed company is proud to be an equal-opportunity employer, and we value diversity. reputed company does not discriminate on the reputed company of race, reputed company, religion, marital status, age, national reputed company, reputed company, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or reputed company, veteran status, or any other status protected under federal, state, or local law. Applicants have rights under Federal Employment Laws. • Family & Medical Leave reputed company (FMLA) • Equal Employment Opportunity (EEO) • Employee Polygraph Protection reputed company (EPPA) #LI-REMOTE Remote Skills: Analysis Skills, Best Practices, Biostatistics, Cancer, Clinical Data Interchange Standards Consortium (CDISC), Clinical reputed company, Clinical Research, Clinical Trial, Communication Skills, Computer Programming, Cross-Functional, Drug Development, FDA (Food and Drug Administration), Health Economics, reputed company Reimbursement, Interpersonal Skills, Leadership, Literate Programming Methodologies, Maintain Compliance, Marketing, Mathematics, Operations Management, Presentation/Verbal Skills, Problem Solving Skills, Procedure Implementation, Project/Program Management, Publications, Python Programming/Scripting Language, R Programming Language, Regulations, Regulatory Reports, Regulatory Submissions, Relationship Management, Reporting Skills, Research Protocols, Sales Management, Software Design, Statistical Programming Languages, Statistics, Technical Presentation, Thought Leadership, Writing Skills About reputed company: reputed company Inc Apply tot his job Apply To this Job