Expert - Manager, CMC Statistics

Novartis • East Hanover, NJ

74d • $103,600 - $192,400

About The Position

The Expert - Manager, CMC Statistics position is focused on understanding business problems and supporting an integrated analytical approach to mine data sources, manage data effectively, and employ statistical methods and machine learning algorithms. The role aims to contribute to solving unmet medical needs, discover actionable insights, and automate processes to reduce effort and time for repeated use. The position requires providing data science and quantitative analytical support by ensuring timely delivery of high-quality reports and building capabilities to leverage the Science of data.

Requirements

• PhD or MS in statistics or other related field with high statistical content.
• PhD or minimum 2 years of relevant industry experience in Biotech or Pharmaceutical drug development and manufacture environment.
• Good understanding in experimental design, statistical methodologies, modeling, and simulations.
• Convey study results with statistical soundness and integrity.
• Experience in Bayesian statistics is a plus.
• Strong computational skills in statistical packages such as SAS, R, JMP, and Minitab.
• Strong oral and written communication skills.
• Efficiently work and collaborate across teams and function areas.
• Demonstrate technical leadership skills.

Nice To Haves

• Experience in Bayesian statistics.

Responsibilities

• Provide statistical leadership and expertise to CMC functions and project teams on the development and implementation of proper study design, statistical analysis, and data interpretation.
• Lead statistical support for CMC projects and participate in reviewing and writing study protocol, analysis plan, statistical report, and/or technical reports.
• Develop statistical models to solve challenging issues in cell and gene therapies CMC domain.
• Support regulatory strategy and preparation of regulatory submissions.
• Participate in the development of intra- and inter-department process and infrastructure.
• Design and conduct statistical trainings to non-statisticians.

Benefits

• Comprehensive benefits package including health, life, and disability benefits.
• 401(k) with company contribution and match.
• Generous time off package including vacation, personal days, holidays, and other leaves.
• Performance-based cash incentive and eligibility for annual equity awards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree