#LI-Hybrid

* Role will be filled at level commensurate with the experience of the candidate

Key Responsibilities:

• Provide strategic 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 and technical reports
• Support regulatory strategy and preparation of regulatory submissions such as IND and BLA and participate in meetings with regulatory agencies
• Develop novel statistical methods to solve challenging issues in cell and gene therapies CMC domain
• Participate in development of intra- and inter-department process and infrastructure
• Design and conduct statistical trainings to non-statisticians

Essential Requirements:

• PhD in statistics or other related field with high statistical content.
• Minimum of 7 years (for Associate Director) or 3 years (for Sr Expert) of relevant industry experience in Biotech or Pharmaceutical drug development and manufacture environment
• Solid understanding in experimental design, statistical methodologies, modeling and simulations. Convey study results with statistical soundness and integrity. Experience in Bayesian statistics is a plus 
• Excellent computational skills in statistical packages such as SAS, R, JMP and Minitab
• Familiar with regulatory guidance, US and international standards such as FDA, EMA, ICH and USP and experience in US and global regulatory submissions
• Exhibit superior oral and written communication skills
• Efficiently work and collaborate across teams and function areas
• Demonstrate mentorship and leadership skills

The pay range for this position at commencement of employment is expected to be between $132,300 and $245,700 /year (Senior Manager) & $145,6000 and $270,400/year (Associate Director); however, while salary ranges are effective from 1/1/25 through 12/31/2025, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.