Senior Principal Biostatistician

Novartis

7+ years

Not Disclosed

India

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: MS/PhD 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 Principal Biostatistician
Location: Hyderabad, India
Company: Novartis
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular

Job Summary:

The Senior Principal Biostatistician is responsible for all statistical work for assigned trials, ensuring scientific and operational excellence in collaboration with the clinical trial team. The role involves leading statistical activities, implementing innovative trial designs and statistical models, and representing Novartis in external scientific discussions. The Senior Principal Biostatistician also mentors junior statisticians and contributes to the continuous improvement of biostatistics methodologies.

Key Responsibilities:

1. Study Level:

Lead statistical tasks for assigned trials, particularly those of medium to high complexity, independently with peer review/input as required.
Responsible for developing protocols, statistical analysis plans, and reporting activities.
Contribute to exploratory analyses, PK/PD analyses, exploratory biomarker and diagnostic analyses, and provide statistical consultation.
Explain statistical methodology and interpret analysis results for stakeholders, ensuring alignment with regulatory requirements.
Contribute to interactions with external review boards, ethics committees, and consultants.
Represent Novartis in external scientific meetings, conferences, and congresses.
Ensure functional alignment with cross-functional teams and drive statistical expertise across trials.
Oversee biostatistics resources and deliverables for assigned trials, ensuring quality and timeliness.

2. Project Level:

May be part of an early project team, representing biostatistics in development plans with oversight.
Collaborate with clinical, regulatory, and other functions to drive quantitative decision-making for assigned indications.
Ensure timely and quality statistical deliverables by collaborating with other functions (e.g., data management, programming, and medical writing).
Propose and implement innovative designs to optimize dose finding and drug development.
Contribute to planning, prioritization, and tracking of biostatistics activities and vendor partnerships.

3. Franchise/Global Line Function Level:

Contribute significantly to initiatives at the global biostatistics line function level, ensuring alignment with best practices and strategic goals.

4. Enterprise Level:

Contribute to organizational improvement initiatives related to cross-functional processes, scientific consulting, and health authority guidance.
Promote the use and acceptance of innovative methods through scientific collaborations, publications, and professional presentations.

5. External Level:

Represent Novartis at external congresses, conferences, and scientific meetings, contributing to discussions on statistical methods and drug development.

6. People Management:

Mentor new hires and junior statisticians, supporting their development within the organization.

Ideal Candidate Background:

Education & Qualifications:

MS in Statistics (or equivalent) with 7+ years relevant work experience, or PhD in Statistics (or equivalent) with 3+ years relevant experience.
Proficiency in statistical software such as SAS or R.

Experience:

Proven experience in all aspects of statistical tasks at the trial level and demonstrated independence in the role.
Expertise in applying statistics to clinical trials, with knowledge of statistical designs, PK/PD analyses, and data exploration methods.
Knowledge of drug development processes and Health Authority guidelines.
Demonstrated success in cross-functional collaboration and working with multidisciplinary teams to achieve objectives.

Skills:

Strong project management and leadership skills, with the ability to influence decisions and drive progress in complex trials.
Excellent communication skills, with the ability to explain statistical concepts to non-statisticians and provide clear justifications for statistical decisions.
Strong business ethics and ability to contribute to innovative scientific discussions and collaborations.

Why Novartis?

Novartis is a global leader in healthcare, committed to improving patient outcomes through innovative medicines. As part of the Novartis team, you will work alongside talented professionals, contributing to breakthroughs that change lives.

Benefits & Rewards:

Discover the full range of benefits and rewards that Novartis offers to its employees at Novartis Benefits.

This role provides an exciting opportunity to lead statistical activities in the clinical trial process, contribute to the development of cutting-edge treatments, and be part of a high-performing team at Novartis.

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