Job title: Director – Biostatistics – Clinical Research
Job description: PRIMARY PURPOSE :
The Director, Biostatistics (India) provides statistical support for clinical research projects including developing and overseeing statistical deliverables, providing guidance and oversight to other senior statistical staff, and ensuring timely and high-quality completion of statistical activities.
In addition to supporting projects, the Director, Biostatistics (India) will serve as the in country lead for biostatistics department staff in the client’s India offices. The Director, Biostatistics (India) reports directly to the Vice President, Biostatistics and will serve as a leader within the global biostatistics department, responsible for providing supervision and oversight of biostatisticians and SAS programmers and supporting corporate activities such as business development, standards, and resource management including staffing and hiring.
– Provides sound strategic, scientific and statistical leadership for clinical trial programs from pre-clinical to Phase IV studies.
– Interacts regularly with external clients and various groups in the execution of clinical research statistical activities domestically and abroad.
– Represents the company at meetings of clinical investigators, Data and Safety Monitoring Committees, and regulatory health authorities such as DCGI. Meeting locations are determined by the client and may require travel outside Bangalore.
– 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.
– 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.
– Leads the team’s development of study analysis plans and statistical programs to perform analyses and display study data.
– Prepares, reviews and/or approves clinical project material that requires statistical input to ensure that the documents are scientifically valid and feasible.
– Reviews work processes, schedules, and checklists to ensure that all routine activities, as documented in corporate and project-specific Standard Operating Procedures (SOPs), are efficiently performed
– Ensures the scientific integrity of the clinical studies and the accuracy of the reported results.
– Manages India’s team of SAS Programmers, Biostatisticians, and Biostatistician Managers and is responsible for statistical deliverables across a broad research area.
– Supervises and provides mentorship to senior statistical staff, promotes career development and growth for senior staff, ensures that department staff are trained and mentored and performs personnel reviews
– Participates in recruiting activities for new biostatistics department staff including screening potential candidates located in India; may make hiring decisions.
– Manages resource utilization for India biostatistics and SAS programming staff in collaboration with the Vice President, Biostatistics
– Contributes to business development and proposal writing
– Fosters innovation in Biostatistics and provides expertise in methodological advances both internally and externally to improve statistical methodologies.
– Identifies statistical and operational issues and proposes solutions.
– Participates in project and corporate quality assurance activities, particularly those of a statistical nature
– Provides data on productivity, quality and timelines regularly to Senior Management
REQUIRED ATTRIBUTES :
Vision and Strategy :
– Sets objectives and key results for defined group or function in alignment with corporate strategy.
– Communicate and implement strategy at the operational level in defined group or function.
Team Building :
– Leads and builds effective teams across broad groups or functions within the organization.
– Foster collaborative relationships across broad groups or functions to ensure an integrated approach to providing services.
– Set and hold Direct Reports accountable for achieving their objectives
– Mentor the next generation of leaders
– Lead change consistent with company objectives
– Problem Solving
– Demonstrated strong problem solving and analytical skills, combined with business judgment
– Oversight of a broad group or function of the organization with responsibilities for successful operations and to deliver service or expertise internally or externally.
– Collect, analyze and provide metrics to ensure delivery of services that exceed customer expectations across defined groups or functions within the organization.
– Setting the cultural tone for broad groups or functions in alignment with company values and providing inspirational leadership through example rather than decree.
– Exemplify company values in all actions and behavior
Credibility and Integrity :
– Developing executive presence and the ability to establish credibility with employees and business partners, the ability to build consensus and achieve goals through influence versus direct line authority.
– Impeccable integrity as a leader and quickly seen as a role- model for leadership
Continuous Improvement/Change Management :
– Promptly take required corrective action when necessary.
– Continually assess the operational effectiveness of structures in place to deliver service and reevaluate approaches and introduce innovations to change paradigms that are ineffective or outdated.
– Bring new ideas and innovative solutions where practical to drive efficiency, enhanced quality and differentiating value to the client.
– Passion for improving human health
– Continuously communicate up, down and across the company to share progress and solutions and future vision.
– Listening skills that embrace cognitive diversity
– Ability to communicate with highly scientific client -management teams
– Stay informed and communicate to others in a supportive manner regarding corporate activities
– Requires a Master’s degree in biostatistics, statistics, or epidemiology with a minimum of 15 years related experience or a PhD strongly preferred in biostatistics, statistics, epidemiology or relevant area with 12 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
– May represent the company 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
– Willingness 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
– Prior CRO experience preferred
Maternity and Paternity Benefits
Job date: Fri, 04 Mar 2022 23:13:08 GMT
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