Job Description
Major Duties And Responsibilities - This position is responsible for providing statistical analysis, direction, and training to service clients in Global Product Development & Supply (GPS) to ensure robust processes and methods, thereby delivering product quality and compliance.
- Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses.
- Support and guidance in relation to study design and data analysis are provided worldwide to the facilities.
- Support the GPS network stakeholders globally to understand their statistical needs and determine sound statistical techniques for use.
- Collaborate with Manufacturing, Manufacturing Science &Technology, and process analytics teams to design studies and analyze complex datasets, driving process robustness and improvement.
- Support Quality Control and Analytical Sciences & Technology teams in method lifecycle management and reference standard qualification, including development, validation, and investigations.
- Develop and implement statistical approaches for study design and data analysis to ensure batch compliance and reduce risks of rejection or recall. This may include Specification setting, Process Capability, Sampling plans, and product shelf life (expiry/retest periods).
- Perform thorough statistical analyses, provide data-driven insights, and recommend actionable solutions aligned with business needs.
- Demonstrates strong statistical expertise while thinking in a clear, conclusive manner. Reaches independent, logical solutions.
- Represent Global Statistics at Product Development, product protocol, and management meetings.
- Contributes to improvement and standardization of processes, procedures, and systems in relation to Statistics while maintaining flexibility where required.
- Furthers the statistical awareness and statistical process control competency of other personnel; participates in their training and development, as needed.
- Enhance statistical awareness across the organization by supporting training and development in statistical methods and process control.
- Foster a shared commitment to quality and compliance at every level.
- Model and reinforce BioPharma Behaviors in daily responsibilities.
Minimum Qualifications - Required MS (with 2+ years of experience) or PhD (with no additional experience) in Statistics, Biostatistics, Applied Mathematics, or other related fields.
- Mastery of statistical methods such as Design of Experiments (DoE), Analysis of Variance (ANOVA), Mixed models, and Multivariate Analysis.
- Advanced skills using one or more statistical software (e.g., JMP, SAS, R, or Python).
- Ability to analyze and interpret scenarios, and through effective study design and statistical analysis, provide answers and appropriate courses of action.
- Capable of managing multiple projects in a dynamic environment.
- Strong communication skills and the ability to explain statistical techniques to non-statisticians.
- Direct experience with CMC-specific statistical methodologies and regulatory requirements
Preferred Requirements - Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background.
- Familiarity with FDA, EMA, and other global regulatory compliance guidelines (e.g., ICH guidelines) related to drug manufacturing, packaging, and distribution.
- Knowledge of Statistical process control, Variance component analysis, and Bayesian methodology.
Benefits Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
Job Tags
Full time, Work at office, Worldwide,