Principal CMC Statistician, Biopharma - Remote (JP9601)
Washington, DC · Biotech/Pharmaceutical
Job Title: Principal CMC Statistician, Biopharma - Remote (JP9601) Location:Washington, DC. (Remote) Employment Type: Contract Business Unit:Quality Science & Technology Duration: 12 months with likely extensions Job posting date: 12/31/2021 Rate: Market Note:Might be asked to give a presentation
3 Key Consulting is hiring a Principal CMC Statistician for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary: 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 internally 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 company’s networks, leading to harmonization, efficiency gains and scientific innovation and, administration of statistical training for company’s engineers and scientists.
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 company’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
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
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
Top 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
Employee Value Proposition: Let’s do this. Let’s change the world. In this vital role you will contribute to compay’s pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Red Flags: No experience in the industry
Interview Process: 1st round: Phone screen 2nd: Panel interview (5 people) We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.