Principal Statistical Programmer

0-2 years

Not Disclosed

India

10 Dec. 25, 2024

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: Senior Statistical Programmer
Location: Hyderabad, India
Company: Novartis
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular

Job Summary:

The Senior Statistical Programmer is responsible for leading statistical programming activities for multiple studies or project-level activities. This role ensures that drug development plans are executed efficiently and that results are delivered on time with high quality, in line with internal and regulatory guidelines. The Senior Statistical Programmer is a key strategic partner in clinical trials, helping to ensure the quality of statistical reporting, data analysis, and project timelines.

Key Responsibilities:

1. Leadership in Statistical Programming:

Lead statistical programming activities for multiple studies or projects, ensuring that data analysis reports and programming aspects meet project specifications.
Propose strategies for study or project execution and make decisions that affect outcomes.
Monitor programming quality, ensure adherence to standards, and support the timely execution of tasks.

2. Cross-Functional Collaboration:

Build and maintain effective working relationships with cross-functional teams, summarizing and discussing key aspects such as schedules, scope, and resource planning.
Act as a representative in study or project teams, ensuring alignment with project goals.

3. Standardization and Knowledge Sharing:

Ensure standardization across projects and studies, providing and implementing programming solutions.
Act as an expert in solving technical problems and driving innovation within the team.
Promote knowledge exchange and continuous improvement across teams.

4. Regulatory Submissions and Safety Reporting:

Oversee the timely and high-quality development and validation of datasets and outputs for regulatory submissions, safety reports, publications, and post-marketing activities.
Ensure compliance with regulatory requirements and industry standards.

5. Innovation and Mentorship:

Generate innovative ideas to enhance the work of the team and project teams.
Mentor and inspire team members, promoting problem-solving and the development of best practices.

6. Compliance:

Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receiving them.
Ensure compliance with marketing regulations, if applicable.

Key Performance Indicators:

Ensure the timely and quality execution of statistical programming and data analysis activities.
Achieve high standards in statistical reporting and adherence to regulatory and internal guidelines.
Drive project success through strategic decision-making and efficient collaboration with cross-functional teams.

Skills & Expertise:

Clinical Research Phases: Expertise in clinical trial design, data review, and reporting.
Innovative Analytical Technologies: Proficient in modern tools and methods for data analysis.
Regulatory Submissions: Experience with drug development and submission processes.
Statistical Programming: Strong command of programming languages (e.g., SAS, R).
Cross-functional Teamwork: Ability to collaborate effectively with various teams to meet objectives.

Required Experience:

Strong experience in statistical programming, clinical trial design, and data analysis.
Proven track record of contributing to clinical studies, ensuring high-quality results, and adhering to timelines.
Knowledge of statistical analysis and data structures.

Language Proficiency:

Fluency in English, both oral and written.

Why Novartis?

Novartis is dedicated to improving patient outcomes by creating innovative therapies. Join a team of passionate professionals who collaborate to achieve breakthroughs that change patients’ lives.

Join the Novartis Network:

If this role does not align with your experience but you are interested in future opportunities, join our talent community here.

Benefits & Rewards:

Learn more about how Novartis helps employees thrive personally and professionally: Novartis Benefits.

This role offers a great opportunity for professionals to take leadership in statistical programming within clinical trials and contribute significantly to the innovative work at Novartis.

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