admin March 21, 2024 No Comments

Clinical SAS Programmer

Job Title: Clinical Statistical Programmer (Medical Devices)
Location: Hyderabad
Job Type: Full-time
Work Type: Work From Office.
About Us: Sylphid Analytics is a global provider of specialized services to the pharmaceutical industry, offering high-quality, practical, responsive, and cost-effective solutions to support biotechnology and pharmaceutical companies. From Phase I to IV clinical trials, we expedite the development of life-saving drugs and devices, focusing on adaptability, quality, and efficiency throughout. Our commitment to excellence ensures that every client experiences complete confidence in our staff’s knowledge, abilities, and reliability, witnessing clear benefits and results from our involvement in their projects. By supporting clients who facilitate the acceleration of drug approvals to market, we contribute to creating a safer and better world, shaping a brighter future for all.
Responsibilities: 
Generate and validate tables, listings, and figures (TLF) based on statistical analysis plan (SAP)
Work with statistician to provide statistical analysis support for publication effort.
Use major statistical programming language to perform data analysis for various needs.
Provide statistical analysis support for post approval studies.
Write specifications and statistical programs to generate analysis datasets and outputs.
Perform data analysis tasks with minimal supervision.
Work with statisticians to develop statistical toolbox for advanced data modelling, tabulation, and visualization.
Participate in reviewing and validating data analysis results.
Qualifications: 
Bachelor’s or master’s degree in a relevant field (e.g., Statistics, Computer Science, Life Sciences).
Minimum of 3-5 years of progressive experience as a statistical programmer in the Medical Devices.
Expertise in SAS programming, including advanced data step programming, macro development, and proficiency with statistical procedures.
Strong knowledge of CDISC standards, SDTM, and ADaM datasets and soon TLF’s.
Demonstrated experience in leading programming activities for regulatory submissions (e.g., FDA, EMA).
Excellent understanding of regulatory guidelines such as ICH-GCP and 21 CFR Part 11.
Exceptional organizational and communication skills, with the ability to effectively collaborate in a team environment.
Preferred Skills:
Experience with other programming languages (e.g., R, Python) is a plus.
At 3+ years’ experience in medical device, pharmaceutical, biotech and/or CRO industries
Strong SAS programming skill in producing various types of outputs such as TLFs and datasets.
Extensive statistical programming experience in producing deliverables either on scheduled or ad hoc basis.
Experience with producing outputs submitted to the FDA and other regulatory agencies.
Excellent organizational skill to prioritize multiple tasks and goals to ensure timely completion.
Attention to detail and able to adapt to a fast-paced environment.
Ability to work both independently and in a cross-functional team.
Excellent communication skills
Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance
Adequate knowledge in clinical trial research methodology, ICH, GCP and regulations
Experiences in medical device and cardiovascular disease is desirable, but not required.
How to Apply: Interested candidates are invited to submit their resume, cover letter, and examples of relevant work here in Apply now. Please include “SAS Programmer Application” in the subject line.

Job Category: SAS Programmer
Job Type: Full Time
Job Location: india
jobs Opening: Work From Office.

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