85 Cdisc Standards Jobs - Page 4

We are seeking a skilled Statistical Programmer with a strong background in R Programming to become a valuable addition to our expanding team. This remote position is ideal for individuals who are enthusiastic about clinical data analysis and programming, particularly those with a deep understanding of CDISC standards. As a Statistical Programmer, your main responsibilities will include developing, validating, and managing SDTM, ADaM datasets, and TLFs in compliance with CDISC guidelines. You will be conducting efficacy analyses using R programming, working autonomously on studies, and providing support for clinical trial submissions. Collaboration with various teams in an FSP environment wi...

As a Senior SAS Programmer at our rapidly growing corporate activities in India, Mumbai, you will play a crucial role in our Biostatistics team. You will have the opportunity to work alongside a dedicated team to complete tasks and projects essential for the company's success. If you are looking for a challenging career where you can utilize your expertise and further develop your skills, this position offers an exciting opportunity for professional growth. Your responsibilities will include proposing and developing specifications for new projects, leading project teams, and writing SAS programs to create analysis datasets, tables, listings, and figures. You will be responsible for programmi...

The ideal candidate for the Biostatistician role should possess a Master's degree in Statistics or equivalent. A Ph.D. in Statistics or equivalent combined with 6 years of industry-related experience is also a preferred qualification. With at least 9+ years of experience, the candidate must demonstrate a deep understanding of statistical and clinical trials methodology as it pertains to clinical development. As a Biostatistician, you will be an integral part of cross-functional development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your role will involve collaborating with various stakeho...

You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user req...

The Clinical Database Programmer (CDP) within the Global Clinical Data Management (GCDM) department is responsible for managing Clinical Data Programming activities. Your role involves ensuring the timely creation, validation, testing, implementation, and maintenance of databases required for all assigned projects. You will analyze study protocols and project requirements, identify data quality rules, and design data entry interfaces in compliance with study protocols, Data Management Plans (DMP), Standard Operating Procedures (SOP), and relevant regulatory requirements and standards. You will be responsible for deploying complete, accurate, and efficient clinical study databases to support ...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent, you will lead and coordinate clinical programming activities and ma...

The Statistical Programmer II position at Princeps Technologies in Hyderabad is a key role within our organization. As a data-driven company specializing in advanced analytics and technology solutions for the pharmaceutical and biotechnology sectors, we are dedicated to innovation, quality, and client success. As a Statistical Programmer II, you will be responsible for developing and validating SDTM datasets according to CDISC standards, creating ADaM datasets following current guidelines, and programming Tables, Listings, and Figures (TLFs) as per sponsor requirements. Your role will also involve generating subject narratives, producing clinical registry files, performing quality control on...

You will be a valued member of our clinical research team as a Statistical Programmer, where your primary responsibility will be to program, validate, and deliver statistical outputs for clinical trials. In this role, you will play a crucial part in ensuring compliance with regulatory standards and industry best practices. Your key responsibilities will include developing and maintaining SAS programs for clinical trial data processing, analysis, and reporting. You will be required to map clinical trial data to CDISC standards (SDTM and ADaM) to ensure compliance with regulatory requirements. Creating and maintaining analysis datasets following CDISC implementation guidelines will also be a p...

Lead clinical trial statistics: develop protocols, design studies, create TLGs, review ADaM specs. Manage statistical deliverables, mentor team, collaborate cross-functionally. Support CTR prep, regulatory submissions, QC validation. Required Candidate profile Postgrad/PhD Statistics. 3+ yrs clinical trial biostatistics experience. Expertise in protocol design & statistical programming (SAS/R). Regulatory submission knowledge. Team leadership abilities.

Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with...