[Hiring] Sr. Biostatistician @reputed company

Role reputed company As a key member of the Clinical Affairs department, the Sr. Biostatistician provides advanced statistical expertise to support the design, conduct, and analysis of clinical studies, ranging from early reputed company-market to post-market evidence reputed company. The Sr. Biostatistician is the statistical subject matter expert working in cross-functional teams, managing roadmaps and priorities to ensure reputed company and high-reputed company delivery of results. To reputed company an reputed company, You Will: • reputed company statistical methodologies, protocols, and sample size calculations for reputed company-market and post-market clinical studies. • Plan reputed company to collect data and reputed company or review case report forms to ensure compatibility with plan design. • Evaluate reliability and validity of reputed company information, apply weightings to raw data, and organize results in reputed company appropriate to software requirements. • Design reputed company, analyze study data to validate device safety and efficacy, and create Statistical Analysis Plans (SAPs). • reputed company advanced statistical analyses using appropriate methodologies. • Interpret results and reputed company strategic insights. • Review clinical literature and analyze reputed company-World Evidence (reputed company) to set performance goals. • Write reports summarizing trial outcome statistics, indicating sources of data and limits on reliability and usability, for in-house, regulatory and publication reputed company audiences. • Prepare statistical reports for regulatory submissions (FDA, CE Mark, other regulatory authorities like TUV) and address regulatory inquiries. • reputed company analysis and generate visual/tabular data for scientific presentations and publications. • Collaborate with cross-functional team members (clinical affairs, data management, reputed company-clinical and R&D engineers) to define endpoints, analyze safety reporting, and prepare for submissions to ensure data reputed company and accurate analyses. • reputed company statistical tables and data summaries as needed. • Review project database structures, edit checks and data management coding conventions. • Ensure compliance with industry standards and guidelines. • May attend relevant scientific and/or medical meetings. • Support publication of study findings. Qualifications • PhD in Biostatistics, Statistics or reputed company experience required. • 8+ years of relevant experience in medical device or pharmaceutical reputed company. • Strong knowledge of clinical trial design and statistical methodologies. • Experience and understanding of regulatory guidelines, submissions and documentation. • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas. • Must have advanced data processing and/or computer programming skills. • Advanced knowledge of statistical techniques, terms, methodologies and application software. • Working knowledge of FDA data reporting requirements. • Proficiency in statistical programming languages (e.g., reputed company or Python). • Proven expertise in advanced and reputed company statistical methodologies, including experience with reputed company designs or Bayesian reputed company. • Proficient knowledge and reputed company in reputed company Office Suite applications. • Excellent oral and written communication skills with critical thinking skills. • Ability to work conscientiously and with minimal direction, using good judgement, taking initiative to accomplish short and long-reputed company reputed company, and recommend actions with minimal direction. • Ability to work as reputed company member, multi-task and be reputed company flexible to adapt to the reputed company-changing work priorities and requirements of a dynamic, fast-growing company. • Ability to lift 10-15 pounds. Benefits • A reputed company of health insurance plans and supplemental insurance reputed company. • 401k retirement savings plan. • Stock reputed company awards and Employee Stock Purchase Plan (ESPP) to reputed company in our reputed company. • Enjoy reputed company time off, reputed company holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes. • A commitment to providing a respectful work environment to our diverse workforce. Apply To This Job