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Principal CMC Statistician

Company: Spectraforce Technologies
Location: West Greenwich
Posted on: January 12, 2022

Job Description:

Principal CMC Statistician
Duration: 12 Months
Location: Remote

As part of the Global Quality Engineering team, the Principal CMC Statistician will use their expertise to implement statistical tools and techniques with science-based practices used throughout the product life cycle. The statistician will support the Final Product Technology team in the development of delivery devices, where they will provide statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification and transfer of physical test methods. They will also establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is compliant with client and Regulatory/ISO requirements. They will support component and material qualifications using process capability analysis and equivalence tests. Ad-hoc statistical support will be provided for root-cause analysis for protocol or method deviations.

The statistician will also provide support to clinical and commercial manufacturing sites in the network. This involves statistical support for monitoring programs, analytical methods and investigations. Finally, the candidate will contribute to continuous improvement efforts across client's networks, leading to harmonization, efficiency gains and scientific innovation and, administration of statistical training for client's engineers and scientists.

Top 3 Must Have Skill Sets:
Must be proficient in statistical programs: Saas code, Jump programs
Designs on experiments, process capability
Showing method or equipment; being able to transfer from one site to another, statistically plan
Must have degree and experience in Statistics, Industrial Statistics or Non-clinical Biostatistics

Primary Responsibilities for the Principal CMC Statistician include:
Acts as a technical lead in the development, implementation and maintenance of statistical tools used to support product life cycle activities. This may include, drafting/updating white papers, writing standardized SAS code, outlining report templates, and aligning relevant SOPs.
Provides continuous statistical support to a site or functional group by consulting with technical associates to develop an experimental study, perform statistical analysis, and document results in a technical report that complies with Amgen's document control system and has statistical integrity.
Supports regulatory audits by interacting with technical staff to answer questions during on- site inspections; and, provides written responses to clarify a statistical approach or perform additional analysis to support a Request for Information, as required.
Participates in improvement efforts to promote statistical techniques used in biologics and monoclonal antibodies processes; and, mentors and teaches statistical techniques and software tools to technical associates.
Stays up to date on biotechnology industry trends, best practices, guidance documents and
Basic Qualifications:
Doctorate degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics or
Master's degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 3 years of applied statistics experience or
Bachelor's degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 5 years of applied statistics' experience or Associate's degree and 10 years of Applied Statistical Experience or

Preferred Qualifications:
Doctorate degree with 5 years' experience in Biopharma manufacturing and control
Proficient in statistical tools and techniques commonly used in biopharma manufacturing operations, such as, Design of Experiments, Statistical Process Control, Process Capability Analysis, Measurement System Analysis, Acceptance Sampling Plans, Non-linear and Linear Regression, Significance Tests, and Simulation.
Proficient in SAS programming (data manipulation techniques, macro, statistical and graphical PROCs, and ODS) and JMP statistical software

Possible Extension:

Red Flags:
*No experience in the industry
*No degree

Interview Process:
1st round: Phone screen
2nd: Panel interview (5 people)

* Might be asked to give a presentation *

Keywords: Spectraforce Technologies, Warwick , Principal CMC Statistician, Other , West Greenwich, Rhode Island

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