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Manager/Senior Manager - Statistical Programming

Lilly
Lilly
5+ years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.