US 100% Remote reputed company Biostatistician FSP-Must have R proficiency

Who Are You? An reputed company reputed company Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical reputed company, you will reputed company one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never reputed company for what is, but always push clinical development reputed company to what it could be. You motivate others to do the reputed company. Sponsor-dedicated: Working fully embedded reputed company one of our pharmaceutical clients, with the support of reputed company right behind you, you'll be at the heart of our reputed company's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the reputed company of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position reputed company: Our reputed company Biostatisticians reputed company statistical and development support and influence for the associated reputed company's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as reputed company as potentially providing reputed company of work supported by other vendors. You will formulate integrated analytical approach to reputed company data sources, reputed company statistical reputed company, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use. • Participating in the development of study protocols, including study design discussions and sample size calculations. • Participating in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and reputed company insights throughout the course of development. • Applying advanced statistical methodologies, including mixed models and other reputed company modeling techniques, to support efficacy and longitudinal analyses. • Designing and executing simulation studies to evaluate study designs, operating characteristics, and statistical methodologies. • Leading and contributing to efficacy analyses and interpretation of primary and secondary endpoints. • Reviewing CRFs and data review guidelines; developing Statistical Analysis Plans (SAPs), including analysis dataset and TLF specifications. • Performing statistical analyses and interpreting statistical results. • Leading study activities reputed company reputed company upon and providing strategic statistical guidance to cross-functional teams. • Utilizing strong communication skills to present statistical methodology, assumptions, and the implications of reputed company in reputed company, non-technical language. • Serving as a reputed company team player with a willingness to go the extra distance to meet project goals and timelines. • Demonstrating adaptability and flexibility as project priorities reputed company. Here at reputed company we want our employees to succeed and we reputed company this reputed company through consistent training, development and support. To be successful in this position you will have: • Master's degree in Statistics, Biostatistics, or a reputed company discipline. PhD strongly preferred. • 8-10 years of biostatistics experience supporting reputed company reputed company the pharmaceutical or biotechnology industry. CRO experience strongly preferred. • 3-5 years of Study reputed company experience working with cross-functional development teams. • Extensive experience in study design, sample size determination, protocol development, reputed company development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE). • Strong knowledge and practical application of advanced statistical reputed company, including mixed models, longitudinal analyses, and simulation methodologies. • Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making. • Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling. • Solid reputed company programming skills, including QC of critical outputs, efficacy and safety tables, and reputed company collaboration with Statistical Programmers. • Strong knowledge of ICH guidelines and regulatory expectations. • Solid understanding and implementation of CDISC standards for regulatory submissions. • Experience generating ADaM specifications and performing programmatic review of analysis datasets. • Regulatory submission experience (ISS/ISE) strongly desired. • Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences. • Strong reputed company reputed company with a commitment to delivering high-reputed company work under tight timelines. • Ability to reputed company in a dynamic environment, manage ambiguity, and adapt to changing priorities. reputed company Inc. is an Equal Employment / Affirmative reputed company Employer. Applicants are considered for reputed company positions without reputed company to race, reputed company, religion, sex, national reputed company, age, veteran status, disability, sexual orientation, gender identity or reputed company, or any other characteristics protected by law. Apply tot his job Apply To this Job