11 Tlfs Jobs

Client discovery, scoping, and requirements (business?side) Lead requirements elicitation with client Medical Writing/Regulatory teams for CSR authoring (template standards, TA nuances, target sections, review cadence, acceptance criteria, quality bars). Translate business goals (timelines, submission strategy, risk tolerance, review workflows) into clear deliverables and negotiate scope, timelines, and costs; manage change requests and approvals. Define done for each CSR section (e.g., Safety Evaluation, Efficacy) including scientific tone, numerical consistency, and ICH E3 alignment; maintain a living Requirements & Assumptions log Translation to technical work (internal hand?off) Soft Ski...

Description Principal Stat Programmer - SDTM, ADAMs & TLFs Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate ...

Role Overview: As a Statistical Programmer II at Princeps Technologies in Hyderabad, you play a crucial role in the organization's data-driven approach to advanced analytics and technology solutions for the pharmaceutical and biotechnology industries. Your focus will be on developing and validating SDTM datasets, creating ADaM datasets, and programming Tables, Listings, and Figures (TLFs) to meet sponsor requirements. Additionally, you will generate subject narratives, produce clinical registry files, perform quality control on programming deliverables, and prepare electronic submission packages in compliance with global regulatory standards. Key Responsibilities: - Develop and validate SDTM...

Job Title: Senior Biostatistician Location: Bangalore/Remote Job Type: Full Time Job Summary: As a Senior Biostatistician, you will lead the statistical design, analysis, and reporting of clinical trials and Real World Data (RWD) studies. You will collaborate cross-functionally with clinical, regulatory, data management, and programming teams, serving as a strategic partner throughout the study lifecycle Key Responsibilities: Oversight and co-ordination of statistical activities in clinical studies and regulatory submissions. Provide statistical expertise in the design, planning, evaluation and documentation of clinical trials and RWD studies. Tasks include but are not limited to: Clinical a...

Job Title: Senior Biostatistician Location: Bangalore/Remote Job Type: Full Time Job Summary: As a Senior Biostatistician, you will lead the statistical design, analysis, and reporting of clinical trials and Real World Data (RWD) studies. You will collaborate cross-functionally with clinical, regulatory, data management, and programming teams, serving as a strategic partner throughout the study lifecycle Key Responsibilities: Oversight and co-ordination of statistical activities in clinical studies and regulatory submissions. Provide statistical expertise in the design, planning, evaluation and documentation of clinical trials and RWD studies. Tasks include but are not limited to: Clinical a...

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...

Company Description CPVIA is a clinical data analytics solutions company based in Hyderabad (India) specializing in statistical programming outsource and statistical consulting services. Our experienced and expert team focuses on accelerating drug development activities across therapeutic areas with increased quality and optimum cost for pharmaceutical, biotechnology, and medical device companies. Role Description This is a full-time on-site role for a SeniorPrincipal Statistical Programmer at CPVIA in Hyderabad, with flexibility for remote work. The Principal Statistical Programmer will be responsible for statistical programming, data management, creating macros, and providing statistical e...

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing mac...

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...

Description Principal Statistical Programmer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solver...

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing mac...