Head, Biostatistics and Data Science

Job Description

• Ensures that biostatistics and data science projects maintain a high quality level with focus on efficiency and timely completion
• Fosters staff career growth and development, providing feedback in positive manner
• Manages resources within team including new hires, terminations and contractors
• Participates in proposal development, bid defenses, audits and company initiatives as needed
• Solves problems creatively, connecting the right technical resources as needed
• Supports innovation, adapting to and communicating process changes as necessary
• Maintains knowledge and expertise in current state-of-the-art tools and healthcare applications in data science
• Leverages methodologies from other industries where applicable to create unique, value added solutions for our sponsors
• Collaborates with US based biostatistics and data science leadership to ensure global thinking and action
• Experience and interest in other biometrics fields including programming and data management a plus

Roles & Responsibilities:

• Oversees and leads the India biostatistics department.
• Works cross-functionally to eliminate risks and barriers that can jeopardize large projects.
• Cooperates with other biostatistics and company departments to optimize global efficiency.
• Builds and manages cross-functional partnerships with internal colleagues and with external partners.
• Demonstrates thought leadership with customers by developing and presenting client industry trends, benchmarking and other pertinent information.
• Understands business concepts and using strategic processes to make good business decisions.
• Represents self and company in a professional manner and in line with core company values.
• Excellent understanding CDISC dataset structures and ensures standards are incorporated correctly into current projects.
• Interacts directly and independently with client to coordinate all facets of the project; expert communicator who has developed strong relationships with client.
• Serves as MMS point of contact with clients and internal teams for matters relating to contractual requirements, deliverable changes, timelines, and deliverables.
• Travels to client sites as necessary.
• Defines and documents client specifications and ensures compliance to customer templates.
• Responsible for planning and on-time delivery of project deliverables that meet quality objectives.
• Responsible for statistical consulting, strategic advice and operational execution in drug/device /diagnostic developments.
• Actively promotes new business by participating in project bids and client presentations as appropriate.
• Provides statistical expertise in designing clinical development programs, individual protocols, optimizing existing protocols, preparing submissions.
• Performs or provides input into complex statistical analyses and statistical reports.
• Participates in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
• Reviews and provides input into critical documents such as CRFs and Data Validation Plans.
• Contributes to the development of detailed statistical analysis plans and output specifications.
• Performs and reviews/QCs statistical analyses for clinical studies in accordance with the protocol, statistical analysis plan, clinical study reports, good statistical practice, and available regulatory guidelines.
• Responsible for all activities of data sciences from pre-discovery to delivery and value realization including data collection, summarization and reporting and provides technical leadership when necessary.
• Strong understanding of data and solution architectures.
• Provide mentorship to data sciences department personnel.
• Strong project management knowledge, including complex projects with multiple team members and independent coordination with the client.
• Strong knowledge of the key technical and non-technical roles needed to support Data Science project end-to-end.
• Guide the decision to choose best-fit data science methodology (statistics, machine learning, optimization, simulation) given the data and applications to achieve goals and objectives.
• Own and facilitate the Discovery phase of Data Science projects.
• Responsible for all deliverables from the Discovery stage up to proposal generation.
• Responsible for project staffing with appropriate resources.
• Demonstrate strong understanding of industry standards.
• Identify new industry trends relevant to data sciences.
• Lead the effort to determine stakeholders needs and ensures business value is realized.
• Educate stakeholders on Data Science methodology to develop appropriate goals.

Compliance

• Demonstrates a strong understanding of CDISC standards, GCP/ICH guidelines, and FDA regulations and takes initiative to suggest and implement biostatistics process improvements and follows through to completion.
• Interacts with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client
• Leads development of components of regulatory submissions (e.g., briefing documents, response to FDA requests, BLA/NDA, and sBLA/sNDA)

Software/ Programs

• Develops and executes complex analysis strategies using efficient programming techniques (software: SAS, R, Python, Julia, Microsoft Power BI).
• Demonstrates extensive knowledge of departmental processes and demonstrates competency with necessary software, such as SAS and nquery.

Managing

• Works with management and stakeholders to identify priorities, goals, and milestones.
• Identifies future risks and provides solutions before the risks become a barrier to producing quality deliverables on time.
• Ensures the departmental goals are met and are in line with company goals.
• Responsible for supporting the development and execution of both short and long term recruitment strategy to ensure the company s growth including providing hiring recommendations of personnel.
• Provides leadership, mentorship, and develops personnel by maintaining a positive work environment.
• Responsible for professional development of colleagues.
• Works with senior management in developing managers and ensuring a talented pipeline of management staff within the department.
• Works with management in other departments to develop business initiatives and process improvements across the organization; solution focused.
• Monitors staff projects quality, timeliness and budgets to foresee and correct issues and assure project expectations are met.
• Gathers and monitors key metrics to assess project performance.
• Effectively assigns and communicates priorities and works direction to ensure completion of assigned tasks on time and within budget.
• Oversees the statistical aspects of clinical trials from design through analysis and reporting.
• Demonstrates extensive knowledge of statistics departmental processes and mentors personnel.
• Leads and implements statistics departmental process improvements.

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Keyskills :
data managementclinical trialsstatistical analysis plansdata collectiondata analyticsproblem solvingdata validationclinical study designmachine learningcdisc standards