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Director Biostatistics

8-12 years
$185,500 – $344,500/year
10 July 1, 2025
Job Description
Job Type: Full Time Education: M.S/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

 

Director Biostatistics | Novartis – East Hanover, NJ, USA

Job Summary:

Novartis is seeking a seasoned Director Biostatistics to lead global statistical strategy and innovation across clinical development and medical affairs. This senior role provides advanced statistical leadership in strategic decision-making, study design, regulatory interaction, and quantitative sciences. As part of the Innovative Medicines division, you'll play a pivotal role in optimizing drug development and ensuring high-impact delivery of biostatistical insights across franchises.


Key Responsibilities:

  • Provide strategic statistical input across drug development phases (preclinical to late phase).

  • Lead statistical planning for regulatory, publication, pricing, and reimbursement strategies.

  • Collaborate cross-functionally with clinical, regulatory, and programming teams.

  • Propose and implement innovative statistical designs and methodologies.

  • Represent Biostatistics and Quantitative Sciences at internal/external decision-making boards.

  • Oversee project-level statistical activities and ensure optimal vendor partnerships.

  • Contribute to the review and implementation of health authority (HA) guidance.

  • Drive statistical communication with external stakeholders and experts.


Required Skills & Qualifications:

  • PhD in Statistics (8+ years) or MS in Statistics (12+ years) of relevant experience.

  • Deep knowledge of statistical methodology in drug development.

  • Demonstrated success with novel approaches in regulatory and clinical strategies.

  • Experience in implementing CDISC standards and working across clinical R&D teams.

  • Understanding of HA guidelines, GCP, and disease-specific statistical models.

  • Strong communication and collaboration skills across global teams.

  • Leadership capability in matrix and cross-functional environments.

  • Fluency in English (oral and written).


Perks & Benefits:

  • Salary Range: $185,500 – $344,500/year

  • Sign-on bonus, restricted stock units, and discretionary awards

  • Full medical, dental, and life insurance coverage

  • 401(k) with company match

  • Paid time off including vacation, parental leave, and sick time

  • Comprehensive career development and leadership training

  • Inclusion in Novartis's global network of scientific excellence


Company Description:

Novartis is a leading global pharmaceutical company reimagining medicine through science and technology. Committed to innovation and patient-centric solutions, Novartis empowers experts to transform healthcare outcomes in oncology, rare diseases, neuroscience, and beyond.


Work Mode:

On-site – East Hanover, NJ (No relocation support provided)


Call-to-Action:

Are you a visionary biostatistician ready to lead transformative drug development? Join Novartis as a Director Biostatistics and drive innovation that improves lives worldwide. Apply now to lead strategic statistical decision-making at one of the world’s most trusted pharmaceutical companies.