Senior Statistical Programmer
India-Hyderabad-Remote
Parexel
For over 35 years Parexel has been a trusted global CRO and biopharmaceutical services company. Learn more about how we can help.When our values align, there's no limit to what we can achieve.
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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Project Management:
- Ability to fill Statistical Programming Lead role on projects
-Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
-Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
-Monitor project resourcing, project budgets, and identify changes in scope.
- Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
- Review statistical analysis plans and mock-shells.
- Review database set-up specifications.
- Interact with sponsors and internal stakeholders with regard to statistical programming issues.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work.
Statistical Programming for Assigned Projects:
- Deliver best value and high quality service.
- Check own work in an ongoing way to ensure first-time quality.
- Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
- Produce/QC dataset specifications and other process supporting documents and submission documentation.
- Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.
Training:
- Maintain and expand local and international regulatory knowledge within the clinical industry.
- Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
- Provide relevant training and mentorship to staff and project teams.
General:
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
- Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
- Proactively participate in and/or lead process/quality improvement initiatives.
- Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
- Represent Parexel at sponsor marketing and technical meetings.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
Skills:
- Looking for 5+ Years of experience with statistical programming.
- Development of the ADaM/TLF programming specification.
- Experience working on the Statistical Analysis Plan.
- Need to have experience on safety and efficacy analysis.
- Expertise in clinical SAS/CDISC programming.
- Creation and validation of ADaM datasets and TLFs.
- Understands the project's timeframe and scope. Independently monitors and completes their own programming tasks.
Knowledge and Experience:
- Competent in written and oral English.
- Excellent communication skills.
Education:
- Educated to degree level in a relevant discipline and/or equivalent work experience.
* Salary range is an estimate based on our AI, ML, Data Science Salary Index π°
Tags: CDISC Consulting GCP SAS Statistics
Perks/benefits: Career development
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