Associate Director, SQS Programming
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 9, 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, Associate 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:
- Leads statistical programming activities for data anonymization
across a compound (or multiple compounds) and related oversight
activities ensuring quality and timeliness
- Sets tasks and prioritization within their compound
- Successfully engages cross functionally to progress tasks with
proven influencing skills
- Leads process improvement initiatives
- Existing internal and external presence on varied statistical
programming topics
- Gains experience in Clinical trial data transparency
anonymization techniques and Risk assessment scorecard statistical
procedures.
- Gain knowledge of redaction rulesets for various sections based
on subjects, disease prevalence or site characteristics.
- Gain expertise with ICH-GCP guidelines for clinical trial
disclosure rules, EudraCT for Data Sharing.
- Gain expertise in anonymization of patient-level data tables
and datasets according to company standard redaction ruleset.
- Gain proficiency in data privacy requirements for publishing
data.CORE ELEMENTS RELATED TO THIS ROLE:
- Provides technical leadership and ensures adequate statistical
programming support for assigned projects
- Ensure successful implementation of Statistical Programming
strategies and efficient execution of the statistical analyses for
the assigned clinical projects
- Applies strong general knowledge of technical and programming
methods with applied experience and can mentorship, matrix or
direct manage staff
- Adhere to CDISC (Clinical Data Interchange Standard Consortium)
guidelines and best practices
- Review and create macros for current and future process
- Contribute to the creation, maintenance, documentation, and
validation of standards for outputs and macros
- Assist in the development of relevant procedures and processes
to ensure that statistical programs are properly documented and
validated
- Work on tables reporting and XML upload from SAS - Macros for
CT.gov and EudraCT
- Evaluate the risk of re-identification for clinical trial
documents internally.
- Carry out all activities according to SOPs and Good Clinical
Practice (GCP) principles, and ensuring adherence to programming
guidelines
- A desire to learn and educate oneself in best practicces for
data anonymization/data sharing.DIMENSIONS AND
ASPECTS:Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry and
statistical programming (e.g., clinical development, the
prescription drug distribution process, etc)
- Participate and engage in external conferences and PHUSE
working groups for data transparency efforts and bring back best
practices in industry to Takeda to improve existing processes.
- Technical expertise at the enterprise level, with a broader
clinical data life cycle awareness
- Excellent communication skills and ability to 'translate'
across functional linesLeadership -
- 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
- Leads one or more assets at GPT level
- Facilitates collaboration cross functionally in GPTs and
generally within DSI and R&D
- Enables the tactical execution of the SQS and DSI vision and
mission
- Leads and accountable for asset level strategies being
implemented
- Mentorship, matrix or direct management of small team of SQS
colleagues
- Creates an internal and external sphere of influence in area of
expertiseDecision-making -and Autonomy -
- Ability to make strategic decisions that impact the statistical
programming function
- Accountable for statistical programming decision making within
their compound
- Participate in and/or lead initiatives that seek diverse input
from multiple constituents and stakeholders to drive innovative
solutionsInteraction -
- 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
- Ability to build strong relationships and collaborate
effectively with other interfacing Takeda functions, including but
not limited to statistics, data management, clinical operations,
medical directors, global program leadsInnovation -
- Forward thinking with the ability to recommend, influence and
implement continuous innovation
- Challenge the status quo and propose forward thinking
innovative solutions
- Implement and embed new ways of working utilizing a wide
variety of software (e.g. SAS, R, Python)
- Identifies opportunities and anticipates changes in the
business landscape through an understanding and ongoing assessment
of the environment affecting the business.Complexity -
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity
- Deep expertise required across statistical programming and
computing environments -
- Ability to see and understand broader, enterprise level
perspective and understand and assess impact to statistical
programming
- Ability to input into best practices with data sharing
- Ability to input into programming and standardization for novel
data such as real world data, digital data, wearable device
dataEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MS with -8+ years of industry related experience.
- BS with -10+ years of industry related experience.
- Proven track record of leading business process transformations
and organizational culture change as well as driving programming
expertise on programs with complex business deliverables
- Operational experience in pharmaceutical drug development with
significant direct exposure to clinical development
- Health care business acumen with a comprehensive understanding
of the pharmaceutical industry
- Health care business acumen with a comprehensive understanding
of -the pharmaceutical industry -WHAT 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.Base Salary Range: $137,200 to $196,000, based on candidate
professional experience level. -Employees may also be eligible for
Short Term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off. - -This posting is made in compliance with Colorado's Equal
Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.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, Cherry Hill , Associate Director, SQS Programming, Executive , Cherry Hill, New Jersey
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