Collaborates with clinical investigators to determine study design
Writes sections of protocols that require statistical input
Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained
Generates treatment allocations in randomized clinical research studies and ensures proper implementation
Leads the project team s development of statistical analysis plans and programs to perform analyses and display study data
Performs statistical analyses, writes and validates application programs
Implements data and safety monitoring reports to ensure participants safety
Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center
Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies
Applies, guides and ensures others on team are implementing QC processes, ensuring deliverables are accurate, are of high quality and delivered on agreed timelines
Authors or contributes to manuscripts and/or scientific presentations
Participates in professional development activities both within and outside the company
Ensure timely and effective communication of project milestones and status to internal stakeholders
Assists the cross functional communication for smooth deliverables of study related documents
Works with multi-disciplinary teams Overview Lead Biostatistician India Bengaluru OR Remote The Emmes Company, LLC ( Emmes ) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation
We believe in the power of truth, so much so that we named our company Emmes, which means truth
Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass
Our Character Achieves Results culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity
We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee from entry level through top executive to contribute to our clients success by sharing ideas openly and honestly
Primary Purpose The Biostatistician collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis and inference and writes and presents reports summarizing findings including publications in peer-reviewed journals
The Biostatistician develops systems for monitoring the quality of clinical data
The Biostatistician ensures high-quality statistical support is provided for clinical trials, registries and basic research using advanced statistical skills and knowledge of clinical research
The Biostatistician maintains expertise in state-of-theart data manipulation and statistical methodology
Responsibilities Collaborates with clinical investigators to determine study design
Writes sections of protocols that require statistical input
Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained
Generates treatment allocations in randomized clinical research studies and ensures proper implementation
Leads the project team s development of statistical analysis plans and programs to perform analyses and display study data
Performs statistical analyses, writes and validates application programs
Implements data and safety monitoring reports to ensure participants safety
Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center
Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies
Applies, guides and ensures others on team are implementing QC processes, ensuring deliverables are accurate, are of high quality and delivered on agreed timelines
Authors or contributes to manuscripts and/or scientific presentations
Participates in professional development activities both within and outside the company
Ensure timely and effective communication of project milestones and status to internal stakeholders
Assists the cross functional communication for smooth deliverables of study related documents
Works with multi-disciplinary teams Qualifications Requires a master s or PhD degree in Statistics with minimum of 6 years of clinical research experience
Solid understanding of design of experiments; Demonstrated proficiency with statistical methods and applications in clinical research
Competent in SAS programming language and/or R
Expertise in state-of-the-art data manipulation and statistical methodology
Ability to effectively communicate technical concepts, both written and oral
Ability to lead / drive departmental initiatives (with Supervision)
Ability to supports recruitment activities in terms of interviewing candidates Flexibility in time management
Employment Type: Full Time, Permanent
Functional Areas: Analytics & Business Intelligence