Job title: CMC Statistician Location: Hybrid role, Devens, 01434 OR New Brunswick site Shift: Work Schedule: Mon - Fri, Business hours Duration: 12 Months
This position is responsible for providing statistical analysis to service clients in Global Product Development & Supply (GPS).
Top 3 Must Have's to be considered for this role: 2+years of statistical analysis experience in Biopharma or Phd ICH guidelines Stability Data, Specification
Major Duties and Responsibilities:
The successful candidate will provide statistical support to Global Product Development & Supply (GPS) in Analytical Strategy & Operations and Manufacturing Science & Technology to ensure product quality, process productivity, robustness, and compliance.
Areas of support include stability analysis, specification setting, statistical application in manufacturing processes, health authority filings, and regulatory responses.
This role offers the opportunity to support the client's product portfolio worldwide with functions in small molecule and biologics development, manufacturing, and supply.
Key Requirements: • Extensive knowledge of statistical methodologies, including regression, ANCOVA, Monte Carlo simulation, tolerance interval, design of experiment (DOE), and statistical modeling. • Familiar with or able to develop an understanding of pharmaceutical stability data and how it is generated and used, e.g. ICH stability guidances particularly statistical analysis for shelf life (ICH Q1E) • General familiarity with the types of chemical/biochemical analyses, the data variability, and good manufacturing practices common in the pharmaceutical industry. • Able to help in the design of stability studies using matrixing and bracketing (ICH stability guidance Q1D) and, where needed, advise in the design of experiments to reduce testing. • Knowledge of pharmaceutical product shelf-life and specification. • Experience in extracting data from a variety of sources, databases, and documents. • Good communication, presentation, and technical writing skills. • Ability to effectively communicate and explain statistical technical information to non-statistician colleagues. • Ability to work independently as well as effectively collaborate with cross-functional teams.
Qualifications: • M. S. with a minimum of 2 years’ experience or Ph. D. in Statistics, Applied Mathematics, Data Science, or Engineering majors with significant academic training in Statistics/Advanced Analytics. • Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS).
Experience / Knowledge Desired: • Knowledge and experience in pharmaceutical or biotechnology industries. • Familiarity with Bayesian statistics. • Some background in sciences to facilitate a subjective understanding of the problems. • Experience in working with a wide range of technically and culturally diverse individuals.
Top 3 Must Have's to be considered for this role: • 2+years of statistical analysis experience in Biopharma or Phd • ICH guidelines • Stability Data, Specification
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $52.00/hr.
