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Associate Director Biostatistics

6-10 years
Not Disclosed
10 June 16, 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

 

Job Summary:

Novartis is hiring an experienced Associate Director Biostatistics for its Hyderabad office. This role offers an opportunity to lead high-impact statistical strategies supporting clinical development, regulatory submissions, and cross-functional collaborations. Ideal for professionals with expertise in statistical analysis, clinical trial design, regulatory standards (CDISC, ICH-GCP), and advanced statistical programming (SAS, R). Join Novartis to contribute to reimagining medicine and improving patient lives worldwide.


Key Responsibilities:

  • Provide statistical leadership for clinical and non-clinical trials.

  • Develop protocols, analysis plans, and reporting strategies.

  • Design innovative trial methodologies and dose-finding strategies.

  • Ensure statistical integrity of regulatory submissions and safety reports.

  • Represent Biostatistics in cross-functional project teams and external forums.

  • Oversee Biostatistics deliverables ensuring high quality and timeliness.

  • Mentor and manage junior statisticians within the global team.

  • Drive adherence to regulatory standards (CDISC, ICH-GCP).

  • Contribute to scientific publications and professional conferences.


Required Skills & Qualifications:

  • PhD (6+ years) or MS (10+ years) in Statistics or equivalent.

  • Strong expertise in SAS, R, and statistical modeling.

  • Knowledge of CDISC, GVP, ICH-GCP, and regulatory guidelines.

  • Experience with clinical development processes and health authority interactions.

  • Proven leadership in cross-functional and global teams.

  • Excellent communication skills for translating statistical concepts.

  • People management and mentoring experience preferred.


Perks & Benefits:

  • Competitive salary and comprehensive benefits package.

  • Opportunities for global exposure and career growth.

  • Inclusive and diverse workplace environment.

  • Access to cutting-edge statistical tools and technologies.

  • Professional development programs and mentoring.

  • Work-life balance initiatives as per Novartis Life Handbook.


Company Description:

Novartis is a global leader in reimagining medicine to improve and extend lives. With a commitment to innovative science, Novartis drives the development of transformative therapies across major disease areas. Known for fostering a diverse and inclusive culture, Novartis empowers its employees to make meaningful impacts on global health.


Work Mode:

On-site – Hyderabad, India


Call-to-Action:

Ready to shape the future of clinical development at Novartis? Apply now to become an integral part of a global pharmaceutical leader and make a difference in patients' lives.