Principal Scientist, Drug Product Development Statistician
Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: June 21, 2022
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Job Description:
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' lives through science. In oncology,
hematology, immunology and cardiovascular disease - and one of the
most diverse and promising pipelines in the industry - each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference.Bristol-Myers Squibb is
seeking an experienced Statistician to join the Engineering
Technologies group within the Drug Product Development function.
Are you looking for a patient-centric company that will inspire you
and support your career? Then join our diverse and innovative team,
where we provide rigorous statistical and data science solutions to
a wide array of assignments, ranging from development to commercial
manufacturing support.**Responsibilities:**+ Uses knowledge and
expertise of statistics to collaborate with scientists in
application of statistics to Drug Product Development: Quality by
Design, formulation development and optimization, process design
and optimization, experimental manufacturing campaigns, determining
manufacturing design spaces, validation and development of
analytical assays, experimental and registrational stability
studies, probabilistic assessment of risk for critical quality
attributes. The successful candidate contributes to the Chemistry,
Manufacturing and Controls (CMC) aspects of biological and oral
solid drug products.+ Analyzes experimental data to support the
development of product specifications and regulatory filings.+
Engages in scientific and technical discussions with
multi-disciplinary team members to move forward with speed and
accountability.+ Clearly communicates and documents results to
stakeholders with diverse backgrounds, including non-technical
audiences.+ Develops visualization techniques to facilitate
interpretation of experimental data and models by
non-statisticians. Trains scientists in data analysis, statistics,
and visualization.+ Applies regulatory guidelines to work and keeps
abreast of technical and regulatory advancements. Authors source
documents used in CMC registrational filings. Assists in developing
responses to health agencies.+ Participates in functional and
cross-functional initiatives, including process and quality
improvements.**Requirements:**+ PhD or MS in Statistics,
Biostatistics, or a related field, with a minimum of 4 years of
relevant industry experience. Candidates with documented equivalent
experience in an applied statistical setting will be considered.+
Pharmaceutical development experience and knowledge of CMC is
desired. Expertise in other scientific/engineering/computing areas
is a plus.+ Advanced knowledge of Design of Experiments (DoE),
multivariate statistics, general linear models and mixed models is
essential.+ Candidate must be proficient with SAS. Experience with
R or S-Plus, and/or JMP is desired.+ Understanding of regulatory
guidelines (e.g. cGMP and ICH guidance) that impact the use of
statistical analysis for setting specifications and predicting
shelf life is preferred.+ A successful candidate will have
excellent computational, written and verbal communication skills,
strong organizational abilities and an ability to work with a
diverse group of scientists and engineers.Around the world, we are
passionate about making an impact on the lives of patients with
serious diseases. Empowered to apply our individual talents and
diverse perspectives in an inclusive culture, our shared values of
passion, innovation, urgency, accountability, inclusion and
integrity bring out the highest potential of each of our
colleagues.Bristol Myers Squibb recognizes the importance of
balance and flexibility in our work environment. We offer a wide
variety of competitive benefits, services and programs that provide
our employees with the resources to pursue their goals, both at
work and in their personal lives.Physical presence at the BMS
worksite or physical presence in the field is an essential job
function of this role which the Company deems critical to
collaboration, innovation, productivity, employee well-being and
engagement, and enhances the Company culture.To protect the safety
of our workforce, customers, patients and communities, the policy
of the Company requires all employees and workers in the U.S. and
Puerto Rico to be fully vaccinated against COVID-19, unless they
have received an exception based on an approved request for a
medical or religious reasonable accommodation. Therefore, all BMS
applicants seeking a role located in the U.S. and Puerto Rico must
confirm that they have already received or are willing to receive
the full COVID-19 vaccination by their start date as a
qualification of the role and condition of employment. This
requirement is subject to state and local law restrictions and may
not be applicable to employees working in certain jurisdictions
such as Montana. This requirement is also subject to discussions
with collective bargaining representatives in the U.S.Our company
is committed to ensuring that people with disabilities can excel
through a transparent recruitment process, reasonable workplace
adjustments and ongoing support in their roles. Applicants can
request an approval of accommodation prior to accepting a job
offer. If you require reasonable accommodation in completing this
application or if you are applying to a role based in the U.S. or
Puerto Rico and you believe that you are unable to receive a
COVID-19 vaccine due to a medical condition or sincerely held
religious belief, during or any part of the recruitment process,
please direct your inquiries to adastaffingsupport@bms.com . Visit
careers.bms.com/eeo-accessibility to access our complete Equal
Employment Opportunity statement.Any data processed in connection
with role applications will be treated in accordance with
applicable data privacy policies and regulations.**Company:**
Bristol Myers Squibb**Req Number:** R1557662**Updated:** 2022-06-17
04:02:45.945 UTC**Location:** New Brunswick,New JerseyBristol Myers
Squibb is an equal opportunity employer. Qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, age, disability, protected veteran status, pregnancy,
citizenship, marital status, gender expression, genetic
information, political affiliation, or any other characteristic
protected by law.
Keywords: Bristol Myers Squibb, New Brunswick , Principal Scientist, Drug Product Development Statistician, Other , New Brunswick, New Jersey
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