Job Title:
Manager/Senior Manager - Statistical Programming
Location:
Bangalore, Karnataka, India
Company:
Lilly
Job Description:
The Manager/Senior Manager - Statistical Programming will collaborate with statistical colleagues and other study personnel to oversee statistical trial analysis. The role involves selecting statistical methods, creating data analysis plans, and conducting analysis once a reporting database is created. This position will also contribute to regulatory submissions, communicate study results, and mentor team members.
Key Responsibilities:
Statistical Trial Analysis:
Collaborate with team members to provide input to statistical analysis plans.
Select statistical methods, author sections of the analysis plan, and conduct analysis.
Maintain proficiency with statistical programming and methodology.
Collaborate on data quality assurance plans and ensure compliance with CDISC data standards.
Communication of Results:
Write reports and communicate study results for regulatory submissions, manuscripts, and one-on-one with key stakeholders.
Respond to regulatory queries and assist in the preparation of responses.
Therapeutic Area and Systems Knowledge:
Understand disease states and competitive landscapes to improve collaboration and customer focus.
Stay informed of technology advances and ensure proper tool/system replication.
Regulatory Compliance:
Perform work in compliance with corporate, medical, and departmental policies.
People Management and Development:
Ensure direct reports have performance and development plans.
Conduct performance reviews and mentor team members.
Manage direct reports' workloads and contribute to talent assessment and succession planning.
Required Qualifications:
Education:
Bachelor’s degree in a related field (e.g., Statistics, Mathematics, Life Sciences).
Experience:
Proven experience in statistical programming with at least 5 years in clinical research or a similar field.
Experience in managing a team and ensuring high-quality work output.
Skills:
Proficiency with statistical programming tools and software.
Strong communication and problem-solving skills.
Knowledge of regulatory and compliance requirements.
Ability to manage multiple projects effectively.
Preferred Skills:
Advanced degree in statistics or related field.
Experience with CDISC standards and data analysis tools.
Leadership experience and team management skills.
Benefits:
Competitive salary and benefits.
Opportunities for career growth and professional development.
Inclusive and collaborative work environment.
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