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.
- 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.
- 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 communicates technical and complex approaches to peers and non-technical colleagues.