Job Posting Title
India Bengaluru
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Director of Biostatistics & Statistical Programming will have several years of leadership level experience in managing people and projects, interacting with clients, and work experience as a Biostatistician developing protocols, writing statistical analysis plans, performing statistical analyses, generating statistical and clinical study reports, overseeing the development and implementation of data management and programming work plans and interacting with project staff and management. The primary role is to lead the Biostatistics and Statistical Programming team at Emmes India and provide sound strategic, scientific and statistical leadership to the division for clinical trial programs from pre-clinical to Phase IV studies.
- Provides sound strategic, scientific and statistical leadership to the division for clinical trial programs from pre-clinical to Phase IV studies.
- Interacts regularly with external clients and various groups within Emmes India, Emmes Canada, and Emmes USA in the execution of clinical research statistical activities domestically and abroad.
- Represents Emmes at meetings of clinical investigators, Data and Safety Monitoring Committees, and DCGI or other regulatory meetings. Meeting locations are determined by the client and may require travel outside Bangalore.
- Develops efficient workflow processes within statistical team and between statistical team and other functional groups including Data Management, Pharmacovigilance, Site Monitors (CRAs), IT, and Regulatory.
- Contributes to business development and securing new clients
- Provides data on productivity, quality and timelines regularly to Senior Management
- Oversees and provides statistical support for clinical research activities including those related to the development of clinical trial protocols, data management strategies, medical monitoring, quality assurance functions and regulatory filings.
- Ensures the scientific integrity of the clinical studies and the accuracy of the reported results.
- Establishes operational objectives and assignments and provides guidance to subordinates to achieve goals in accordance with established policies.
- Ensure high quality deliverables fm Emmes Biostatistics (India) programming/statistics team; lead after action reviews, share learnings and implement solutions
- Mentors staff on statistical and statistical programming tasks and helps staff gain management and leadership level experience.
- Leads the team's development of study analysis plans and statistical programs to perform analyses and display study data.
- Makes hiring decisions and conducts performance reviews for statistical staff.
- Manages resource utilization and budgets for statistical team.
- Authors the protocol statistical section, incorporating appropriate statistical methods for study design and analysis; and the results sections of the clinical study report and/or scientific publication.
- Fosters innovation in Biostatistics and provides expertise in methodological advances both internally and externally to improve statistical methodologies.
Participates in the development and updating of Standard Operating Procedures and adheres to corporate standards for documentation and validation of Biostatistics methodologies
- Requires a Master's Degree in biostatistics, statistics, epidemiology with a minimum of 10 years related experience or a PhD strongly preferred in biostatistics, statistics, epidemiology or relevant area with 8 years related experience, or equivalent.
- Demonstrated proficiency with statistical methods and applications in clinical research.
- Demonstrates proficiency in statistical programming languages including SAS and R.
- Good knowledge and experience in managing Biostatistics project teams
- Good understanding of GCP principles and other regulatory standards in Clinical Research.
- Excellent organizational and communication (written and oral) skills, ability to manage multiple tasks, ability to work independently, as well as in a team environment and a desire to improve skills; possesses effective and excellent communication skills and is capable of presenting ideas and data clearly to a group; demonstrates effective listening/communication skills to influence colleagues and stakeholders at a project, matrix and/or departmental level; Ability to translate complex technical (statistical/programming) methodologies to cross-functional teams (other drug research & development colleagues)
- As part of Industry presence & influence, may represent Emmes at external professional/ industry organization meetings and work on industry-wide issues (e.g., ICH working group, CDISC). Will have good knowledge and awareness of leading edge statistical/programming methods and standards used in industry
- Wwillingness to adjust behaviors and priorities based on changing environment
- Ability to make prudent decisions to achieve desired outcomes, seeking help and input as needed; recommends solutions
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