Senior Manager, Programming
Company: Takeda Pharmaceutical
Location: Clifton
Posted on: May 19, 2023
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 Description
OBJECTIVES/ PURPOSE
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 .
A CCOUNTABILITIES
- Be able to support PK programming needs for successful data
reporting activities by providing hands on programming support
.
- Deliver assigned projects with quality and timeliness
- Sets tasks and prioritization within their projects
- Support generat ion of NONMEM datasets for PK /PD analysis
including maintenance of the variable definition file
- Deliver complex calculations with in NONMEM dataset build and
PK modeling accordance of specification by partnering QCP
colleagues .
- Create/QC NONMEM dataset(s) created by others/external
programmers .
- Generate e-submission package for NONMEM (or other modelling
type) analysis. (e.g., NONMEM control file, output parameter files,
output table files and other files ) and maintain supportive
documentations .
- Work and engage cross functionally to deliver PK/PD analysis
and i nteract /communicate with external v endors in data
collection, data formatting, data presentation .
- Lead cross departmental PK/PD data reporting trainings as
needed.
- Experience with data plotting in R is desired ( e.g.
ggplot2).
- Carry out functional responsibilities in accordance with
applicable SOPs and Regulatory requirements
- Provide hands on Support internal decision making modelling
tasks
CORE ELEMENTS RELATED TO THIS ROLE
- Provides technical s upport and ensures adequate statistical
programming support for assigned projects
- Contribute in cross-functional communication to establish
future-fit internal data flow and processes
- Support and provide programming activities for assigned P K/PD
projects
- Partner with QCP colleagues to ensure successful implementation
of Statistical Programming strategies and efficient execution of
the statistical analyses for the assigned P K/PD projects
- Str ong communication skills to lead team discussions
- Strong knowledge of CDISC data standard and regulatory
submission activities
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise (Breadth and depth of
knowledge, application and complexity of technical knowledge)
- Comprehensive understanding of the pharmaceutical industry and
statistical programming (e.g., clinical development, the
prescription drug distribution process, etc.)
- Excellent analytical, technical, and computer skills
- Advanced SAS programming ability
- Strong knowledge of CDISC standards, medical terminology,
clinical trial methodologies, and FDA/ICH regulation Leadership
(Vision, strategy and business alignment, people management,
communication, influencing others, managing change)
- Demonstrated ability to work across functions, regions and
cultures
- Excellent communicator, able to convey both ideas and data,
verbally and in writing
- Operate as an effective team player who can work engagingly
with others
- Ability to disti l complex technical programming ideas in s
imple comprehensible terms
- Embraces and demonstrates a diversity and inclusion
mindset
- Owns assigned tasks, identifies the need for and actively seeks
input from others
- Engages cross functionally to progress tasks by
influencing
- Leads activities and parts of projects including studies or
exploratory work related to clinical drug R&D
- Establishes internal and external presence on topics of
interest Decision-making and Autonomy ( The capacity and authority
to make organizational decisions , autonomy in decision-making,
complexity of decisions, impact of decisions, problem- solving )
- Provide input to strategic decisions that impact the
statistical programming function
- Accountable for statistical programming decision making within
study level
- Participate in initiatives that seek diverse input from
multiple constituents and stakeholders to drive innovative
solutions
Interaction (The span and nature of one's engagement with others
when performing one's job , internal and external relationships)
- Effectively understands the changing external and internal
environment
- 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 lim i ted to statistics, data management, clinical operations
Innovation (The required level of scientific knowledge, knowledge
sharing, innovation and risk taking)
- Comfortable ch alleng ing the status quo and bringing forward
innovative solutions
- Ability to recommend technical solutions using a wide variety
of software ( e.g. SAS, R, Python)
- Ability to communicate ideas around possible innovative
solutions, and possibly ways to accelerate existing milestones
Complexity ( Products managed, mix of businesses, internal and/or
external business environment, cultural considerations )
- Ability to work in a global ecosystem (internal and external)
with a high degree of c om p l exity
- Expertise required across statistical programming and computing
environments
- Ability to see and understand broader, enterprise level
perspective
- Awareness of best practices with data sharing
- Awareness of programming input and standardization for novel
data such as real world data, digital data, wearable device
data
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
- MS with 6 + years of industry related experience.
- BS with 8 + years of industry related experience.
- Proven track record of contributing to business process
transformation and organizational culture change as well as
providing 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
ADDITIONAL INFORMATION
- This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
- Base Salary Range: $ 130,200.00 to $ 186,000.00 . Employees may
also be eligible for Short Term and Long-Term Incentive benefits.
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.
- The final salary offered for this position may take into
account a number of factors including, but not limited to,
location, skills, education, and experience.
EEO Statement
Takeda 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.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Clifton , Senior Manager, Programming, Executive , Clifton, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...