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Manager, Quality Data Support

1 month ago

Princeton NJ, United States Sun Pharmaceutical Industries, Inc. Full time

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.