Senior Principal Statistician
Company: Akebia Therapeutics, Inc.
Posted on: June 12, 2021
The Senior Principal Statistician is a highly strategic Quality
role that will help to align best practices of using data analytics
and statistical analysis for technical and cross-functional/cross
company business issues. This role is expected to provide in depth
technical knowledge and leadership in the areas of analytical data
analysis to support the Akebia Quality Control and Quality
Assurance functions. The position requires an experienced
pharmaceutical scientist / with a proven track record of applying
statistical analysis techniques in the areas of Quality Control,
specifically related to release and stability data.
This position will serve to support growth and expansion of
Akebia's Quality Control function. The ideal candidate will
develop, implement, and drive improvement of data analytics and
business processes that include but are not limited to both process
and method capability analysis. The incumbent will identify risks
and adverse trends related to analytical data for both clinical and
commercial products. The Sr. Principal Statistician will work
extensively with colleagues inside and outside Quality to drive
improvements related to the analytical data analysis and trending
to support the Global Stability and Quality Operations teams. The
Sr. Principal Statistician will support investigations and expiry
extension efforts as well as contribute to routine data monitoring
and completion of critical regulatory filings and requirements for
both clinical and commercial objectives (e.g., Annual Product
Review, stability trending reports, expiry extension). Sr.
Principal Statistician may lead high level cross functional teams
utilizing project management skills to implement and improve key
business processes and will oversee activities of lower-level
- Develop and standardize complex statistical analysis techniques
to support analytical evaluation of clinical and commercial
analytical data to support routine trending, identification of
eroding trends, technology transfer and routine commercial product
- Make use of statistical software packages and other data
manipulation software packages in the evaluation of Product Quality
Review, in-process product, and special investigation data on a
regular basis for all products.
- Lead teams through complex problem-solving methods and perform
in-depth analysis of tangible and intangible factors to determine
cause and effect.
- Work collaboratively across functions to collect, trend, and
report analytical data to be utilized to support investigations,
validations, and process improvements.
- Design and develop statistical applications for use by others
for ongoing monitoring and analysis of internal/external data.
- Work with colleagues within and outside Quality to drive and
embed improvements to analytical trending processes throughout the
- Analyze data from investigation evaluations, summarizes
conclusions and makes recommendations for further work where
- Generate quarterly reports analyzing data from within Akebia's
- PhD in statistics or biostatistics with at least 6 years of
relevant pharmaceutical industry experience
- MS in statistics or biostatistics with at least 8 years of
relevant pharmaceutical industry experience
- BS with at least 12 years years of pharmaceutical industry
- Pharmaceutical Development, Statistical/Data analytic support
of commercial manufacturing and/or research experience
- Experience working with multiple manufacturing
sites/laboratories, including contract manufacturing / laboratories
is highly desired.
- Familiarity with data analytics tools
- Expert understanding of CPV and its applications
- Ability to understand and simplify complex processes
- Impact across both commercial and development programs
- Knowledge of cGMP, ICH and Regulatory CMC guidance documents
specific to the role.
- Lean/six-sigma training and applications experience. Able to
coach less experienced colleagues within the function
- Thorough knowledge of pharmaceutical testing
- Strong knowledge of the relevant cGMP, ICH and global
Regulatory CMC guidance documents applicable to the function.
Akebia Therapeutics, Inc. is a fully integrated
biopharmaceutical company focused on the development and
commercialization of therapeutics for people living with kidney
disease. The Company was founded in 2007 and is headquartered in
Cambridge, Massachusetts. For more information, please visit our
website at www.akebia.com.
Akebia is an equal opportunity employer and welcomes all job
applicants. All qualified applicants will receive consideration for
employment without discrimination on the basis of race, color,
religion, sex, sexual orientation, gender identity, national
origin, protected veteran status, disability, or any other factors
prohibited by law.
Keywords: Akebia Therapeutics, Inc., Cambridge , Senior Principal Statistician, Other , Cambridge, Massachusetts
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