Specialist CMC Statistician

Amgen Technology Private Limited

1 - 3 years

2 - 4 Lacs

Hyderabad Telangana India

Posted:1 month ago| Platform: Foundit logo

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Skills Required

Continuous Improvement Biopharmaceutical Manufacturing Process Control

Work Mode

On-site

Job Type

Full Time

Job Description

Specialist CMC Statistician

Responsibilities

Statistical Support:
Provide continuous statistical support to manufacturing and functional groups by designing experimental studies, performing statistical analyses, and documenting results in technical reports.
Regulatory Compliance:
Prepare written responses and perform additional analyses to support regulatory submissions and address questions from agencies.
Tool Development:
Participate in the development and maintenance of statistical tools used for product lifecycle activities, including drafting white papers, writing standardized code in
R and SAS
, and creating report templates.
Continuous Improvement:
Contribute to improvement efforts by promoting statistical techniques in biologics and monoclonal antibodies processes. You will also mentor and guide technical associates on statistical methods and software.
Knowledge & Training:
Stay updated on industry trends and guidance documents, participating in external conferences as appropriate. You will also administer statistical training for engineers and scientists.

Qualifications

A Doctorate degree in
Applied Statistics, Industrial Statistics, or Non-clinical Biostatistics
, or a Master's or Bachelor's degree with relevant experience in a similar field.
Proven experience applying statistical methodologies to support
Biopharma manufacturing and control
.
Proficiency in a wide range of statistical tools and techniques, including
Design of Experiments, Statistical Process Control, Measurement System Analysis
, and
Acceptance Sampling Plans
.
Advanced proficiency in
SAS and/or R programming
, as well as
JMP statistical software
.
Excellent interpersonal, oral, and written communication skills.

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