Manager Statistical Programming
Company: Sun Pharmaceutical Industries, Inc.
Location: Skillman
Posted on: October 20, 2024
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Job Description:
Manager, Statistical Programming
Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth
largest specialty generic pharmaceutical company in the world with
global revenues of over $ 5 billion US Dollars. Supported by more
than 40 manufacturing facilities, we provide high-quality,
affordable medicines, trusted by healthcare professionals and
patients, to more than 100 countries across the globe including the
United States. Sunology is a combination of Sun Values and Ideology
and is the way of life at Sun Pharma. Sunology is Humility.
Integrity. Passion. Innovation. It represents our promise to all
stakeholders including patients, physicians, and employees.
Description:
Sun is seeking a Manager, Statistical Programming within its
Clinical Development organization in Princeton, NJ. The Manager,
Statistical Programming will provide comprehensive programming
expertise to lead and support all programming activities as per the
project strategies. The incumbent should be able to work
independently implementing and executing the programming and
project standards to support ongoing clinical studies and requests
for study report, regulatory submission, and ad hoc/post hoc
analysis. The incumbent will work closely with internal partnering
functions, stakeholders, and external functional service providers
to ensure all the programming deliverables are delivered in timely
manner with high quality. The incumbent will participate in and
contribute to department goals, SOPs, macros, SME topics and act as
a technical expertise to provide guidelines on complex programming
tasks and standards.
Responsibilities:
Lead statistical programming activities for a therapeutic area or
compound/indication within multiple studies/projects in various
study activities to ensure timely and high-quality programming
deliverables in assigned projects and areas.
Develop and maintain programming documentations following
programming standards and processes. Create CDISC standard SDTM
mapping specifications and ADaM specifications.
Develop and oversee the development of SAS programs for the
creation of SDTM and ADaM datasets following CDISC standards and
reports (Tables, Listings and Figures).
Contribute to the development of standard macros, participate in
establishing and maintaining statistical programming standards.
Participate in the CRF annotation, review of SAP, TLFs
specifications development and TLFs review.
Handle all P21 related items and eCRT package including aCRF,
define.XML, cSDRG, ADRG and ARM for the regulatory submission to
FDA/EMA/PMDA or other agencies.
Support global regulatory authority submissions following the
guidelines (sdTCG, DSC, eCTD etc.) and working closely with
partnering functions to address health authority requests.
Demonstrate company values by demonstrating excellence, competence,
collaboration, innovation, respect, ownership, team work and
accountability.
Understand the scope of work, plan and complete the deliveries and
timelines with the study team, programming lead and management.
Participate and contribute towards department goals, SOPs, training
guidelines and SME topics.
Mentor and Coach new hires and junior programmers.
Qualifications:
Minimum Bachelor's degree in Statistics, Computer Science,
Mathematics, Engineering, Life Science or related discipline
8+ years of programming experience in processing clinical trial
data in the biotechnology, pharmaceutical, CRO or health care
related industry.
Preferred Qualifications:
Proficiency in SAS programming skills in a clinical data
environment with excellent analytical skills. Working knowledge of
other programming languages such as R, Python etc. is a plus.
Great knowledge of pharmaceutical clinical development (i.e.,
understanding of statistical concepts, techniques, and clinical
trial principles) and regulatory submissions (NDA, ANDA etc.).
Great working knowledge of implementing CDISC standards, Regulatory
guidance and TAUG.
Ability to work independently and on global interdisciplinary
teams. Good organizational, interpersonal, and communication
skills. Positive attitude, team player and growth mindset.
Problem solving and innovative skills that demonstrate initiative
and motivation.
Hands-on programming as well as people and process management
experience.
Demonstrated and applied SAS programming skills. SAS certificates a
plus.
Actual base compensation may vary based on a number of factors,
including but not limited to geographical location and experience.
In addition, this position is part of the Annual Performance Bonus
Plan. Employees are eligible to participate in Company employee
benefit programs which include medical, dental and vision coverage;
life insurance; disability insurance; 401(k) savings plan; flexible
spending accounts; and the employee assistance program. Employees
also receive various paid time off benefits, including vacation
time and sick time.
The compensation and benefits described above are subject to the
terms and conditions of any governing plans, policies, practices,
agreements, or other materials or documents as in effect from time
to time, including but not limited to terms and conditions
regarding eligibility. If hired, employee will be in an "at-will
position" and the Company reserves the right to modify base salary
(as well as any other discretionary payment or compensation
program) at any time, including for reasons related to individual
performance, Company, or individual department/team performance,
and market factors.
The preceding job description has been designed to indicate the
general nature and level of work performed by employees within this
classification. It is not designed to contain or be interpreted as
a comprehensive inventory of all duties, responsibilities and
qualifications required of employees as assigned to this job.
Nothing herein shall preclude the employer from changing these
duties from time to time and assigning comparable duties or other
duties commensurate with the experience and background of the
incumbent(s).
We provide equal employment opportunities for all current employees
and applicants for employment. This policy means that no one will
be discriminated against because of race, religion, creed, color,
national origin, nationality, citizenship, ancestry, sex, age,
marital status, physical or mental disability, affectional or
sexual orientation, military or veteran status, generic
predisposing characteristics or any other basis prohibited by
law.
Keywords: Sun Pharmaceutical Industries, Inc., Vineland , Manager Statistical Programming, Executive , Skillman, New Jersey
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