Statistician (Pharmaceutical industry)
We have an immediate opening for a Statistician (Pharmaceutical industry) at our Deerfield Beach, Florida headquarters.
Our company provides final assembly, labeling and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill finish capabilities. Scientist and Engineers work closely with our partners to continuously create and introduce innovative, patient centric, solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their counterparts at the partner company to develop and maintain program timelines in line with the strategic and business needs of our partners. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved as well as have one clear point of responsibility.
The Statistician will provide excellence and expertise in statistical support to the site in order to drive the application of advanced and state-of-the-art statistical principles, tools, and methodologies with the goal of improving process understanding, product quality, and compliance, as well as driving efficiency, process capability, and profitability. Duties Include:
- With supervision and guidance, provide technical support to Quality, Program Management, Development, Process Development (Manufacturing and Analytical Sciences), and Regulatory & Compliance with hands-on analysis of process and product data.
- Apply appropriate routine statistical methods in order to improve and to maintain optimal process control and product compliance.
- Explain and justify application of statistical methods in discussions with internal and external regulatory bodies and health authorities.
- Carry out other duties as assigned.
Process validation and design transfers
- Analyse and interpret process validation data in order to demonstrate validity and equivalence, e.g., between tools.
- Contribute to the construction and interpretation of failure mode and effects analysis (FMEA) and fault tree analysis (FTA).
- Identify and evaluate tests to qualify and to validate the design of new products and processes to ensure fitness for use.
· BS in Statistics, Mathematics, Engineering, or other related field required.
· Fluent (verbal and written) in English language required.
· 1+ years of experience within the Medical Device, Manufacturing, or Pharma industry preferred.
· Proven proficiency in data science and applied statistics required, e.g., in DOE and
multivariate data analysis including regression and ANOVA
· Proficiency with statistical software required, e.g., JMP, Minitab, SPSS, SAS, R
· Proficiency in Microsoft Office (Word, Excel, PowerPoint) required
· Experience with regulatory agencies and standards preferred, e.g., FDA and ISO
· Experience analyzing and applying GLPs and GMPs to improve the quality of the system preferred
Ability to analyze situations thoroughly, identify potential problems, find and implement effective solutions.
We have an excellent benefits package and offer a salary that is based on experience and accomplishments.
If you possess the required experience and qualifications and want the challenge of growing with our company then submit your resume in confidence to our Human Resources Department at RecruitUS@shl-group.com.