Manager/Senior Manager - Statistical Programming
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-83331
Purpose:
The purpose of this role is to manage and oversee statistical programming tasks to ensure high-quality data analysis and effective communication of results while managing a team and adhering to regulatory requirements.
Primary Responsibilities:
Statistical Trial Analysis:
Collaborate with statistical colleagues and study personnel to provide input to statistical analysis plans.
Assist in selecting statistical methods for data analysis, author the corresponding sections of the data analysis plan, and create the reporting database.
Conduct data analysis after creating the reporting database.
Coordinate with data sciences in planning and implementing data quality assurance plans.
Justify the selected methods and implement previously outlined analysis plans.
Conduct peer review of work products from statistical colleagues.
Maintain proficiency in statistical programming, methodology, and application of new methods.
Stay up to date with CDISC data standards.
Utilize current technologies and available tools for clinical trial analysis.
Communication of Results and Inferences:
Collaborate with statistical colleagues to write reports and communicate results.
Assist in communicating study results via regulatory submissions and manuscripts.
Respond to regulatory queries in collaboration with other statistical colleagues.
Therapeutic Area and Systems Knowledge:
Understand relevant disease states and competitive landscapes to enhance customer focus and collaboration.
Ensure replication of tools and systems where applicable and stay informed of technological advancements.
Regulatory Compliance:
Perform work in full compliance with assigned curriculum(s).
Follow applicable corporate, medical, local, and departmental policies, procedures, processes, and training.
People Management and Development:
Ensure all direct reports have a Performance Management (PM) and Development plan in place.
Conduct mid-year and final PM reviews to evaluate performance, business results, and impact.
Provide appropriate input on merit increase and promotion activities.
Develop direct reports through coaching, mentoring, and timely feedback.
Manage the workload of direct reports effectively.
Contribute to employee development, talent assessment, and succession planning.
Encourage appropriate rewards for deserving individual/group performance.
Ensure all direct reports adhere to company policies, procedures, and regulations.
Minimum Qualification Requirements:
Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, or a related field.
Strong knowledge of statistical programming languages (e.g., SAS, R).
Proven expertise in statistical programming and data analysis.
Strong understanding of CDISC standards, clinical trial analysis, and regulatory requirements.
Strong project management and communication skills.
Demonstrated ability to lead and mentor a team effectively.
Other Information/Additional Preferences:
Knowledge of therapeutic areas and related disease states.
Experience in regulatory submissions and responding to regulatory queries.
Strong problem-solving abilities and attention to detail.
Limited travel, up to approximately 10%.
Lilly’s Commitment:
Lilly is committed to providing equal opportunities to individuals with disabilities. If you require accommodation during the application process, please complete the accommodation request form at Lilly Accommodation Request.
Lilly is an equal opportunity employer.
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