Director, Programming
Company: Takeda Pharmaceutical
Location: Bronx
Posted on: May 12, 2022
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAre you looking for a patient-focused,
innovation-driven company that will inspire you and empower you to
shine? Join us as a Statistical Programming, Director.At Takeda, we
are transforming the pharmaceutical industry through our
R&D-driven market leadership and being a values-led company. To
do this, we empower our people to realize their potential through
life-changing work. Certified as a Global Top Employer, we offer
stimulating careers, encourage innovation, and strive for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.Here, you will be a vital
contributor to our inspiring, bold mission.POSITION
OBJECTIVES:Takeda SQS is looking to add individuals to our team
that are team oriented, collaborative, strong understanding of the
statistical programming function, exceptional leaders and
innovators. - Takeda is a global, values-based, R&D-driven, top
10 biopharmaceutical leader committed to discover and deliver
life-transforming treatments, guided by our commitment to patients,
our people and the planet. -To attract and retain the very best
talent, we in Takeda SQS are open to flexible or remote working for
some roles. - Such roles will have a connection to a Takeda R&D
-center. -POSITION ACCOUNTABILITIES:
- Develops and executes strategic plan related to training for
all SQS Programming staff and partnered vendors to meet the needs
of the business and ensure GcP compliance -
- Develops and executes training and education strategy for new
statistical software and technology platforms in partnership with
leadership from Chief Statistical Office, Technology and
Operations
- Evaluates industry trends and best practices with respect to
cutting-edge tools and novel programming approaches that leverage
machine learning, AI, and metadata driven processes to determine
organizational fit
- Leads development strategy and writing of programming processes
and associated documentation -
- Develops expertise in all SQS processes to support and ensure
inspection readiness
- Interface with cross-functional subject matter experts and
quality organization in preparation for audit and inspection
planning, implementation and follow-up
- Leads strategic discussions, ownership, maintenance and content
collaboration for department website and related document
repositories -
- Successfully engages cross-functionally to progress tasks with
proven influencing skills
- Leads process improvement initiatives to successful
completionCORE ELEMENTS RELATED TO THIS ROLE:
- Solid project management, leadership and problem-solving skills
with the ability to execute on plans with limited direction and
support
- Proven conceptual thinking and strategic problem-solving
ability
- Ability to prioritize and lead various team members at various
levels to achieve goals
- Ability to write detailed procedure and policy documents based
upon discussions with process owners and in compliance with
technical writing standards and to provide mentoring in this area
for others in the organization
- Excellent people management skills
- Proven ability to distill technical jargon and communicate
effectively
- Well developed expertise in strategic and analytical
thinking
- Demonstrated flexibility to adjust to a broad range of
responsibilities
- Solid knowledge and experiences with GCP regulatory
inspections
- Proven ability to adapt to change and manage cultural change in
an evolving environment.
- Demonstrated initiative in staying abreast on current industry
topics as they relate to functional areaDIMENSIONS AND
ASPECTS:Technical/Functional (Line) Expertise
- Possess a comprehensive understanding of the pharmaceutical
industry and statistical programming ecosystem (e.g., clinical
development, the prescription drug distribution process, etc)
- Possess technical expertise at the enterprise level and
specifically related to technical writing standards
- Capable of leading cross-functional teams addressing a wide
variety of the organization's needs
- Demonstrate expertise in industry trends and regulatory policy
initiatives inclused GcP, CRF 21 Part 11 compliance, and other ICH
guidelinesLeadership -
- Ability to partner with colleagues and leadership to understand
process needs and gaps
- Demonstrated ability to work and influence across functions,
regions and cultures
- Excellent communicator, able to persuasively convey both ideas
and data, verbally and in writing
- Functional level leadership with the ability to inspire,
motivate and drive results
- Proven skills as an effective team player who can engender
credibility and confidence within and outside the company
- Ability to distil complex technical ideas in simple
comprehensible terms in order to influence decisions and
outcomes
- Cross functional leader and influential decision maker that has
direct impact on assets and functions
- Key decision maker in training strategies and enabling tactical
implementation
- Proactively creates and implements sub-strategies to enable the
promotion of SQS and DSI vision and mission within TAUs, BUs, and
R&D functions
- Mentorship, matrix or direct management of - team supporting
SQS operations
- Leader both within and outside of Takeda in area of expertise
for organizational initiativesDecision-making -and Autonomy -
- Provide input to highly complex decisions that impact the
statistical programming function
- Accountable for decision making for the statistical programming
function
- Ability to seek diverse input from multiple constituents and
stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are
implemented swiftly to yield flawless execution -
- Accountable for providing input to and implementing vision and
strategy for designated scopeInteraction -
- Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
- Ability to effectively implement R&D's partnership strategy
as it applies to statistical programming and statistics
- Ability to build strong relationships and collaborate
effectively with other interfacing Takeda functions, including but
not limited to statistics, data management, information technology,
clinical operations, regulatory, and the data sciences organization
-
- Cultivates a broad network of relationships throughout Takeda,
with affiliates and external partners, in the industry and area of
expertise.
- Effectively represents function in negotiations with the
ability to resolve conflict in a constructive manner
- Demonstrates flexibility in an ever evolving
landscapeInnovation -
- Forward thinking with the ability to recommend, influence and
implement organizational change and continuous innovation
- Challenge the status quo and propose forward thinking
innovative solutions
- Ability to take risks implementing innovative solutions,
accelerating time to market
- Identifies opportunities and anticipates changes in the
business landscape through an understanding and ongoing assessment
of the environment affecting the business.
- Models respect and inclusion in all interactions, creating a
culture that fosters innovationComplexity -
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity
- Ability to see and understand broader, enterprise level
perspective - and understand -and assess impact to statistics
organizationEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BA/BS in data science, statistics or a related field with
minimum of 10 years of relevant experience in pharmaceutical
industry. MA/MS/MBA a plus..
- Demonstrated knowledge of clinical research with emphasis on
statistics and statistical programming
- Intermediate level proficiency in SAS, R, Python or other
programming language.
- Understanding of CDISC standards and associated submission
requirements
- Experience in developing training plans and curriculum
- Experience with building, planning and executing training and
educational courses
- In-depth understanding of compliance risks facing the
pharmaceutical industry with a particular focus on issues facing
the clinical organization
- Experience in problem solving, negotiations, and collaborative
team building with non-direct reports and other stakeholders
- Experience in writing technical documentation and standard
operating procedures
- Experience in managing projects towards process improvements
-
- Operational experience in pharmaceutical drug development with
significant direct exposure to clinical development
- Health care business acumen with a comprehensive understanding
of the pharmaceutical industryWHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
Plan
- Tuition reimbursement Company match of charitable
contributions
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters
Please.In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.Absent an approved religious or medical
reason, all US office-based and lab-based Takeda employees who work
fully on-site or in a hybrid model (as determined by Takeda) must
be fully vaccinated to work at a Takeda site or to engage with
Takeda colleagues or anyone else on behalf of Takeda. US
field-based employees must be fully vaccinated as a condition of
employment, absent an approved religious or medical reason. US
employees who work at a Takeda manufacturing facility, and those
who work at a BioLife center or BioLife lab, may be subject to
different guidelines. If you are contacted by a Takeda recruiter
about your job application, we encourage you to seek more
information on the applicable guidelines for the Business
Unit/Function to which you have applied.#LI-SGM -EEO
StatementTakeda is proud in its commitment to creating a diverse
workforce and providing equal employment opportunities to all
employees and applicants for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, gender
expression, parental status, national origin, age, disability,
citizenship status, genetic information or characteristics, marital
status, status as a Vietnam era veteran, special disabled veteran,
or other protected veteran in accordance with applicable federal,
state and local laws, and any other characteristic protected by
law.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, New Rochelle , Director, Programming, Executive , Bronx, New York
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