Director, Programming
Company: Takeda Pharmaceutical
Location: North Chelmsford
Posted on: May 16, 2022
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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 Privacy Notice and Terms of Use. 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 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, 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 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
OperationsEvaluates 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 fitLeads development strategy and writing
of programming processes and associated documentation Develops
expertise in all SQS processes to support and ensure inspection
readinessInterface with cross-functional subject matter experts and
quality organization in preparation for audit and inspection
planning, implementation and follow-upLeads strategic discussions,
ownership, maintenance and content collaboration for department
website and related document repositories Successfully engages
cross-functionally to progress tasks with proven influencing
skillsLeads 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 supportProven
conceptual thinking and strategic problem-solving abilityAbility to
prioritize and lead various team members at various levels to
achieve goalsAbility 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 organizationExcellent
people management skillsProven ability to distill technical jargon
and communicate effectivelyWell developed expertise in strategic
and analytical thinkingDemonstrated flexibility to adjust to a
broad range of responsibilitiesSolid knowledge and experiences with
GCP regulatory inspectionsProven 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) ExpertisePossess 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 standardsCapable of leading cross-functional
teams addressing a wide variety of the organization's
needsDemonstrate 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
culturesExcellent communicator, able to persuasively convey both
ideas and data, verbally and in writingFunctional level leadership
with the ability to inspire, motivate and drive resultsProven
skills as an effective team player who can engender credibility and
confidence within and outside the companyAbility to distil complex
technical ideas in simple comprehensible terms in order to
influence decisions and outcomesCross functional leader and
influential decision maker that has direct impact on assets and
functionsKey decision maker in training strategies and enabling
tactical implementationProactively creates and implements
sub-strategies to enable the promotion of SQS and DSI vision and
mission within TAUs, BUs, and R functions Mentorship, matrix or
direct management of team supporting SQS operationsLeader 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 functionAccountable for decision making for the
statistical programming functionAbility to seek diverse input from
multiple constituents and stakeholders to drive innovative
solutionsAbility 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 workplaceAbility to
effectively implement R's partnership strategy as it applies to
statistical programming and statisticsAbility 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 mannerDemonstrates
flexibility in an ever evolving landscapeInnovation Forward
thinking with the ability to recommend, influence and implement
organizational change and continuous innovationChallenge the status
quo and propose forward thinking innovative solutionsAbility to
take risks implementing innovative solutions, accelerating time to
marketIdentifies 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 complexityAbility 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
requirementsExperience in developing training plans and curriculum
Experience with building, planning and executing training and
educational coursesIn-depth understanding of compliance risks
facing the pharmaceutical industry with a particular focus on
issues facing the clinical organizationExperience in problem
solving, negotiations, and collaborative team building with
non-direct reports and other stakeholdersExperience 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 developmentHealth care
business acumen with a comprehensive understanding of the
pharmaceutical industryWHAT TAKEDA CAN OFFER YOU: 401(k) with
company match and Annual Retirement Contribution PlanTuition
reimbursement Company match of charitable contributionsHealth &
Wellness programs including onsite flu shots and health
screeningsGenerous time off for vacation and the option to purchase
additional vacation daysCommunity 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-SGMEEO 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, Boston , Director, Programming, Executive , North Chelmsford, Massachusetts
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