[Hiring] Biostatistician Manager @Emmes Group

Role Description

Oversees statistical activities and deliverables across a project or platform of related clinical research studies, leads a team of Statisticians and SAS Programmers and ensures that statistical deliverables are completed in a timely manner and with high quality. Serves as a lead statistician on multiple clinical research studies, from the initial design stage all the way to final report writing and manuscript preparation.

• Collaborates with clinical investigators to determine study design.
• Writes sections of protocols that require statistical input; Applies novel, quantitative decision making techniques to improve study design, analytical approach.
• 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.
• Develop and follow SOPs for validation of statistical analysis programs. Maintain high quality of the outputs.
• Develop macros and functions for repetitive statistical analysis programs etc.
• Provide input to clinical study report / manuscript through statistical interpretation of study results during interim, final reporting of the study.
• Support in results presentation to the DSMB, study teams etc.
• Participates in professional development activities both within and outside the company.
• Ensure timely and effective communication to all stakeholders.
• Coordinate with internal/external stakeholders/vendors and other functions (Medical Monitor, Data Managers, SAS programmers) within study team for smooth deliverables of study related documents.
• Maintains awareness of current statistical literature and researches new techniques.
• Contributes to departmental strategies and initiatives (India and Global).
• May contribute at governance board meetings (e.g. DSMB/SMC).
• Provides input on responses to audit/inspection questions and assists in completing CAPAs within agreed timelines.
• Uses networking skills to collaborate with peers or other functional groups (e.g. clinical, DM, IT, medical writing etc.).
• Supports recruitment activities.
• May take line management activities.

Qualifications

• Requires a master’s or PhD degree in Statistics with minimum of 8 years of clinical research experience.
• Strong understanding of design of experiments; Demonstrated proficiency with statistical methods and applications in clinical research.
• Demonstrates good understanding of biostatistics processes.
• Competent in SAS programming language and/or R.
• Expertise in state-of-the-art data manipulation and statistical methodology.
• Experience with clinical database technologies, data models and statistical programming.
• Ability to manage multiple tasks.
• Ability to work independently, as well as in a team environment.
• Ability to effectively communicate technical concepts, both written and oral.
• Demonstrated ability in enterprise thinking (e.g. analytical thinking and solutions beyond study level).
• Ability to communicate technical and complex approaches to peers and non-technical colleagues.

Company Description