India Job Openings
Cytel, India
Senior Statistical Programmer
September 4, 2024
The Senior Statistical Programmer has the following resonsibilities:
- Provides significant technical expertise for statistical programming, development of automated reports and preparation of submission data standard packages.
- Participates in all phases of programming support.
- Supports statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.
- Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures).
- Responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups.
- Key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
- May serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol.
- Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
- Maintain and manage a project plan including resource forecasting.
- Coordinate the activities of the supplier’s programming team; interacts with Merck statistical programmers.
- Strong project management skills; leadership at a protocol level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.
- Designs and develops complex programming algorithms.
- Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
- Good Exposure to R-Programming
- Expertise in CDISC , SDTM and ADa M standards.
Qualifications & Experience:
- Master's degree, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- 7+ years of SAS programming experience in the Pharmaceutical & Biotech industry.
- Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience
- Very good experience in writing and reviewing programming specifications
- 2 years of study lead experience, preferably juggling multiple projects simultaneously strongly desired
- Ability to implement the latest CDISC SDTM / ADa M standards
- Strong ADa M experience, which includes pooling of datasets for ISS
- Familiar with Define.xml and reviewers guide (SDRG, ADRG)
- Knowledge of statistics
- Very good knowledge on e-submission preparation is strongly preferred
- Ability to provide solutions for complex programming issues (includig creation of complex macros), presenting alternatives and identifying best solution.
- Have good expsoure to R-programming.
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