Sr. Principal Biostatistician

Overview Lead Biostatistician India Remote/Bengaluru(hybrid) 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-the-art 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 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 Good organizational and communication (written and oral) skills, ability to manage multiple tasks, ability to work with minimum supervision, as well as in a team environment and a desire to improve skills Professional speaking abilities for routine internal and/or external communication purposes

Be willing to learn and adapt to new processes and procedures