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Job details
-
NATURE OF JOB
Hybrid — WFH / WFO / CW
- CATEGORY Programming
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SALARY RANGE
Best in the industry Annual
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EXPERIENCE
1 – 3 Years
- JOB TYPE Full Time
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REGIONAL PREFRENCES
India
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NO. OF VACANCIES
1
Job description
Job Description
< u>< strong>40 + different analysis including clinical trials, scientific analysis, health authority responses, publication requests, patient access services, etc., are being worked upon at any point of time. The Statistical Programming team is a dynamic function where we are empowered to experiment, explore and progress beyond the boundaries of best-in-class Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide.
Job Purpose
The Senior Statistical Programmer is responsible for all programming aspects (including analysis datasets, pooled datasets, listings, figures, and tables) of Medical Affairs (MA) studies, non-interventional studies (NIS), and to support scientific analytic studies. May also support individual Phase II-IV clinical trials or other project level activities for small drug project indications (or equivalent), as agreed with customers. Supervise CROs as required to ensure timeliness of deliverables with highest quality.
Your key responsibilities:
Your responsibilities include, but are not limited to:
< u>< strong>40 + different analysis including clinical trials, scientific analysis, health authority responses, publication requests, patient access services, etc., are being worked upon at any point of time. The Statistical Programming team is a dynamic function where we are empowered to experiment, explore and progress beyond the boundaries of best-in-class Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide.
Job Purpose
The Senior Statistical Programmer is responsible for all programming aspects (including analysis datasets, pooled datasets, listings, figures, and tables) of Medical Affairs (MA) studies, non-interventional studies (NIS), and to support scientific analytic studies. May also support individual Phase II-IV clinical trials or other project level activities for small drug project indications (or equivalent), as agreed with customers. Supervise CROs as required to ensure timeliness of deliverables with highest quality.
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Responsible for the integrity of the programming computing solutions for multiple clinical trials (or equivalent) and or publication activities.< li>
- Is the scientific lead for programming expertise liaising with Statistical and clinical counterparts within the study project team, across multiple projects< li>
- Is responsible for the full execution of final production output generation (tables, listings and graphics) for projects as the Trial Programmer, ensure high quality for all deliverables, and follow the processes. May lead programming activities for a relatively small project or an indication with guidance from Subject Matter Experts (SMEs)< li>
- Maintain effective interfaces with internal and external customers with support of vendor management, Principal Programmer Statistician and Group Leads as needed.< li>
- In conjunction with the statistician, responsible for development of programming specifications of analysis datasets and pooled datasets, study-level programming standards and ensure compliance with project-level company standards. With guidance, may provide support to development of project-level programming standards, following internal guidelines.< li>
- Ensure that study documents and specifications are consistent and comply with company standards by providing input into eCRF and data structures, tables, listings and figures for studies and submission activities.< li>
- Responsible for programming (according to specifications) analysis datasets, pooled datasets, listings, tables, and figures for studies and for Summary of Clinical Safety (SCS) and Summary of Clinical Efficacy (SCE) with high quality and within milestones.< li>
- Responsible for preparing Case Report Tabulations for the regulatory submission as required.< li>
- Responsible for QC compliance and archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality deliverables.< li>
- Review planning of edit checks; assist non-standard, complex data validation programming as needed according to agreed plans for the assigned study project.< li>
- Assume the role of subject matter expert domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance.< li>
- Provide input on process improvement initiatives and participate in non-programming project activities.< li>
- Maintain up-to-date knowledge of programming software (e.g. SAS R S-plus) and guide junior programmers as and when needed< li>
- Provide programming expertise in developing selecting modifying basic intermediate MACROs for reporting standards.< li>
- Supervise the activities of the vendors as needed.
< li> < ul> Minimum Requirements
< u>< strong>- BA BS MS equivalent experience in mathematics, statistics, computer science, or health sciences related field with At least 5 years’ work experience in a programming role preferably supporting clinical trials or in the pharmaceutical industry (3 years for MS Statistics Computer Science graduates).< li>
- Strong knowledge of experience with SAS< li>
- and other relevant programming software.< li>
- Good knowledge of database design structures and basic statistics.< li>
- Strong understanding of global clinical trialpractices, procedures, methodologies.< li>
- Strong understanding of regulatory relevant to statistical programming (e.g. GCP, ICH).< li>
- Intermediate knowledge of office tools.
< li> < ul>Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https: talentnetwork.novartis.com network
Division
< strong>CTS
Business Unit
< strong>NBS CONEXTS
Country
< strong>India
Work Location
< strong>Hyderabad, AP
Company Legal Entity
< u>< strong>Nov Hltcr Shared Services Ind
Functional Area
< strong>Research & Development
Job Type
< strong>Full Time
Employment Type
< strong>Regular
Shift Work
< strong>No
Early Talent
< strong>No < div>< body>< html>
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