3 Tlf Generation Jobs

Job Summary: The Sr. Statistical Programmer will be responsible for end-to-end statistical programming in clinical trials, including SDTM, ADaM datasets, and tables, listings, and figures (TLFs). The role involves collaborating with biostatisticians, sponsors, and project teams to ensure high-quality programming outputs, compliance with regulatory guidelines, and efficient project delivery. Key Responsibilities: Develop custom programming code using SAS or other software to generate summary tables, listings, graphs, and derived datasets according to SAP and programming specifications. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies. Maintain organized, complete, and up-to-date project documentation, testing, and verification/quality control programs. Manage multiple projects, set priorities, and adapt daily workload according to project timelines. Develop specifications for datasets and outputs of varying complexity according to statistical and sponsor requirements. Anticipate and address potential programming issues to establish efficient programming practices. Prepare and contribute in internal meetings, sponsor meetings, kickoff meetings, and bid defense meetings. Act as lead statistical programmer, directing programming activities of other personnel and monitoring progress on deliverables. Review project documentation such as SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs. Provide feedback to project team members to reduce inefficiencies and improve programming quality. Mentor programming personnel, develop training materials, and guide new associates in programming processes. Transfer deliverables and perform other work-related duties as assigned. Minimal travel may be required. Qualifications: 5+ years of experience in Clinical Statistical Programming. Expertise in end-to-end programming, including SDTM, ADaM, and TLFs. Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills; ability to read, write, speak, and understand English.

Job Summary: The Sr. Statistical Programmer will be responsible for end-to-end statistical programming in clinical trials, including SDTM, ADaM datasets, and tables, listings, and figures (TLFs). The role involves collaborating with biostatisticians, sponsors, and project teams to ensure high-quality programming outputs, compliance with regulatory guidelines, and efficient project delivery. Key Responsibilities: Develop custom programming code using SAS or other software to generate summary tables, listings, graphs, and derived datasets according to SAP and programming specifications. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies. Maintain organized, complete, and up-to-date project documentation, testing, and verification/quality control programs. Manage multiple projects, set priorities, and adapt daily workload according to project timelines. Develop specifications for datasets and outputs of varying complexity according to statistical and sponsor requirements. Anticipate and address potential programming issues to establish efficient programming practices. Prepare and contribute in internal meetings, sponsor meetings, kickoff meetings, and bid defense meetings. Act as lead statistical programmer, directing programming activities of other personnel and monitoring progress on deliverables. Review project documentation such as SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs. Provide feedback to project team members to reduce inefficiencies and improve programming quality. Mentor programming personnel, develop training materials, and guide new associates in programming processes. Transfer deliverables and perform other work-related duties as assigned. Minimal travel may be required. Qualifications: 5+ years of experience in Clinical Statistical Programming. Expertise in end-to-end programming, including SDTM, ADaM, and TLFs. Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills; ability to read, write, speak, and understand English.

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 programming deliverables, and preparing electronic submission packages that adhere to global regulatory standards. The ideal candidate for this position is a SAS programmer with over 4 years of experience in clinical trial data analysis. You should be proficient in SAS Base and Macro programming, particularly for SDTM, ADaM, and TLFs, and have knowledge of clinical domains such as safety, efficacy, and PK/PD. Familiarity with CDISC standards, metadata programming, and sponsor-defined analysis standards is essential, while experience with Therapeutic Area User Guides (TAUGs) and R programming would be advantageous. To be successful in this role, you should possess strong documentation, quality control, and regulatory compliance skills. A Bachelor's or Masters degree in Statistics, Life Sciences, Computer Science, or related fields is preferred, along with experience in preparing submission-ready data and documentation. Effective communication and collaboration skills are valued, as is an understanding of regulatory expectations from agencies like the FDA and EMA. Joining Princeps Technologies means becoming part of a talented and mission-focused team dedicated to global clinical research and regulatory innovation. You will have the opportunity to work in a supportive environment with onsite collaboration in Hyderabad, along with competitive compensation and professional development prospects.,