6.0 - 10.0 years

0 Lacs

pune, maharashtra

On-site

Role Overview: As a Senior Statistical Programmer at ProcDNA, you will leverage your advanced SAS and R programming skills along with proficiency in CDISC standards to support or lead one or more Clinical studies. You will be part of a passionate team that focuses on creating game-changing Commercial Analytics and Technology solutions for clients globally. Innovation is not just encouraged at ProcDNA, it is ingrained in our DNA. Key Responsibilities: - Having 6+ years of experience in SAS & R Programming - Hands-on experience with SDTM, ADAM, TLF including safety and efficacy analysis - Experience with CRF annotation, creation of datasets, and specs creation - Submission experience is a plus (define.xml, P21, ADRG, SDRG) - Able to lead 1 study under supervision - Demonstrates strong programming and domain expertise - Ability to execute a wide range of programming activities with minimal supervision - Identifying gaps in current programming best practices and offering suggestions - Ensuring adherence to standards and having an awareness of evolving industry standards - Developing an understanding of all applicable policies and procedures - Completing programming activities under supervision - Taking responsibility for timely completion of all assigned development tasks - Understanding and applying a basic knowledge of the industry Qualifications Required: - Experience working with RWD for use in pharmacoepidemiology research with practical knowledge in biostatistics applied to clinical/epidemiological research - Expertise in commonly used Real World Databases (Optum, Marketscan, Flatiron, JMDC, etc.) within the Real World landscape - Proficiency in R with expertise in other programming languages such as SQL or Python - Familiarity with AI/ML, data visualization, and reporting tools (Note: Additional details about the company are not provided in the job description),

Posted 5 days ago

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Programmer Analyst ProcDNA

3.0 - 7.0 years

0 Lacs

karnataka

On-site

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 300+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey We are currently seeking a Programmer Analyst with a strong hands-on experience in EDC platforms such as Medidata RAVE, InForm, Central Designer, or Veeva Studio. The ideal candidate will possess a solid understanding of clinical data standards, protocol interpretation, and the ability to build high-quality, compliant EDC databases. As a Programmer Analyst, you will play a crucial role in supporting the end-to-end development of clinical databases and ensuring data integrity throughout the trial lifecycle. Your responsibilities will include interpreting clinical trial protocols to design eCRFs and build databases using Medidata RAVE, InForm, Central Designer, or Veeva Studio. You will be responsible for configuring systems, implementing edit checks, dynamic rules, and custom functions (C# for RAVE) based on DVS. Additionally, you will conduct technical and functional reviews, support Sponsor Acceptance Testing (SAT), and ensure accuracy across all database components. You will also manage protocol amendments, metadata updates, lead ICRM/SAM meetings, and resolve issues in QC, UAT, and production environments. Handling migrations, RFCs, and post-go-live activities, generating sponsor reports (JReview, SAS, BOXI), acting as DB Coordinator across trials, and mentoring junior team members will also be part of your role. Key Requirements: - 3 to 5 years of hands-on experience with at least one EDC platform such as Medidata RAVE, InForm, Central Designer, or Veeva Studio (combination preferred). - Proficiency in eCRF design, edit checks, dynamic rules, and custom functions (e.g., C# for RAVE). - Solid understanding of clinical trial protocols, DVS interpretation, CDPS/SDV strategy, CRF annotation, and post-go-live activities, including migrations and RFCs. - High attention to detail with strong adherence to ICH GCP and clinical data standards. - Excellent written and verbal communication skills for effective team and sponsor collaboration. - Educational background in BE/B.Tech, M.Sc./MCA, or B.Sc./BCA in Computer Science or a related stream with consistent academic performance of 60% or above in 10th, 12th, and graduation.,

Posted 1 month ago

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