50 Tlf Jobs

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),

Hiring for Statistical Programmers with strong experience in end-to-end programming ( SDTM, ADaM, TLF ) for a leading Clinical Research organistaion. Location: Remote Role & responsibilities Title: Senior Statistical Programmer Experience: 6+ years Skills Required: Technical: R (expert), Python (proficient), SQL (proficient), experience in IHD software Experience in RWD , mainly in Pharmacology and Epidemiology (post-marketing) Hands-on experience with Real World Databases Optum, Marketscan, Flatiron, JMDC Familiarity with AI/ML, Data Visualization, and reporting tools to apply share Resumes with Puja.k@maxisclinical.com Regards Puja Khemchandani

Join Clarios industry-leading Digital Physiology team as a Principal Statistical Programmer, where your expertise will drive innovation in clinical research. This is a unique opportunity to lead advanced statistical programming for cardiac safety trials, shaping the future of digital health through cutting-edge data science and global collaboration. What you'll be doing Statistical Programming & Data Standards Lead and coordinate all statistical programming activities for cardiac safety trials. Develop, test, and maintain SAS code to generate CDISC-compliant datasets (SDTM, ADaM). Produce and maintain submission-ready datasets and electronic submission packages (e.g., define.xml, reviewer’s guide) in accordance with FDA guidelines. Team Leadership & Mentorship Manage direct reports in a line or matrix capacity, including work allocation, resource planning, and professional development. Conduct onboarding and training on statistical programming practices and SOPs. Mentor junior staff and provide guidance on programming methodologies and quality standards. Process Improvement & Strategic Initiatives Identify and implement process improvements to enhance operational efficiency. Develop and maintain SOPs, SWIs, templates, and playbooks for programming deliverables. Drive initiatives for future analyses, data quality, and standardization. Cross-functional Collaboration & Project Management Collaborate with cross-functional teams to define scope and timelines for statistical deliverables. Manage client commitments and ensure timely delivery of assigned projects. Maintain accurate tracking of deliverable statuses and dates. What we're looking for Ph.D. with 5+ years of relevant industry experience, M.S. with 7+ years of relevant industry experience or B.S. with 10+ years of relevant industry experience A degree in medical, health, public, or general science—or an equivalent combination of education and experience sufficient to perform job duties Strong experience in clinical trials , preferably within a CRO or pharmaceutical research organization Proficiency in SAS programming , including creation, testing, and maintenance of CDISC-compliant datasets (SDTM, ADaM) Experience with electronic submission packages and regulatory interactions (e.g., FDA) Familiarity with clinical protocols and Statistical Analysis Plans Experience with TFL generation is a plus Solid understanding of the pharmaceutical drug development process At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

Experience in leading a team of statistical programmers for a compound/indication or therapeutic area Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle Good to have experience in other statistical programming languages (R). In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience etc.) Experience with regulatory filings. Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations). Contact Person - Sangeetha Tamil Email - sangeetha@gojobs.biz

- Experience Required: 5+ years into clinical SAS Programming Requirements: - Strong experience in Base SAS, Advance SAS - Must have good experience in ADaMs, table, listing and figure creation. - Good to have study lead exposure.

Minimum experience: 8 years. We're seeking someone who brings: Extensive hands-on experience in End to End programming A strategic mindset and the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes If you're ready to take on a high-impact role with a global sponsor we’d love to connect!

ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion

ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages [Define.xml], and Reviewers guide [RGs] for all the deliverables Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells Setup the folder structure for the assigned study as per the SOP Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects Provide the study status to the Project Manager/Client periodically Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate. Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as the accuracy and reliability of statistical analysis results To ensure that the assigned team members are in compliance with SOPs and training requirements

ROLES and RESPONSIBILITIES: Perform statistical programming review of case report forms (CRFs), annotated CRFs, database structures, statistical analysis plan (SAP) project documentation such as Statistical Analysis Plan (SAP), mock shells, programming specifications and annotated CRFs Provide the statistical programming support for assigned studies, in both production and QC of analysis dataset specifications, analysis datasets, statistical analysis tables, data listings, figures, and statistical appendices Provide the status of assigned tasks to Study Lead Programmer and Project Manager Identify, communicate, and manage study-based risks and issues Maintain supporting documentation for studies in accordance with SOPs, Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to development of Statistical Programming standards and processes to improve quality, efficiency, and effectiveness Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results Adhere learning and develop knowledge on the latest in CDISC Therapeutic standards, GCP and applicable ICH guidelines

Position Summary The Principal Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. The Principal Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, the Principal Statistical Programmer will write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. The Principal Programmer will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels and/or participate in department and/or company initiatives. Position Responsibilities/Accountabilities Creation of safety and efficacy SAS datasets. Creation of SDTM and/or ADaM specifications. Creation of project specific macros and formats. Creation of CDISC compliant DEFINE, SDRG, ADRG. Serve as Statistical Programming subject matter expert (SME) as needed. Performing data checks as needed, to ensure integrity and correctness of data displays and to understand structure and content of data. Perform QC/validation of datasets, tables, listings, figures to verify the output with high efficiency. Establish, maintain, and strengthen professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations. Ensure the quality and integrity of data analysis and reporting. Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to management. Contribute to the development of functional-level standards, tools, and templates. Interact across operational areas as required. Interact with sponsor representatives as required. Position Qualification Requirements : Education : Bachelors Degree in Computer Science/Mathematics or equivalent. Masters degree preferred. (A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience.) Experience : A minimum of 7 years of relevant work experience. Hands on Experience with CDISC/SDTM/ADaM Programming including but not limited to SAS: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development. Capable of conducting exploratory statistical analyses using statistical software packages. Experience developing custom SAS programs. Experience with P21 reporting and DEFINE, SDRG, ADRG development. Creation of annotated CRFs Previous experience in pharmaceutical research or CRO setting. Base or Advance SAS certification preferred. Required Certifications : N/A Required Skills : Proficient with Microsoft Office 365 Suite (Outlook, Excel, Word, PowerPoint, Project preferred). Excellent verbal, written, and interpersonal skills. Knowledge of clinical trial study design. Ability to train staff on company macros and standards and programming approaches used on studies. Able to work independently on multiple, concurrent projects. A high degree of accuracy and attention to detail. Can attend study team meetings as needed. Excellent presentation skills. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow for self and study teams. Ability to track, report, and escalate as needed on study level financials and resourcing needs. Ability to work on a SAS server environment using windows-based PC SAS. Versatility, flexibility, and a willingness to work within constantly changing priorities. Proven ability to handle multiple projects and meet deadlines. Ability to deal effectively with a diversity of individuals at all organizational levels. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Good judgement with the ability to make timely and sound decisions. Ability to be discreet with sensitive company information. Ability to travel for meetings or training activities may be required

. Roles and Responsibility • Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. • Program and plan the integration of databases from multiple studies or sources. • Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department, for complex studies. • Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of statstical team lead for single complex studies or group of studies. • Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and resource forecasts for single studies. May manage project budget and resource requirements, and provide revenue forecasts for single studies. • Provide training and guidance to lower level staff. Qualifications: • Master's Degree Computer science or related field and 3 years relevant experience Req Or • Bachelor's Degree Computer science or related field and 4 years relevant experience Req • Equivalent combination of education, training and experience in lieu of degree Req • Knowledge of statistics, programming and/or clinical drug development process • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language • Good organizational, interpersonal, leadership and communication skills • Ability to effectively manage multiple tasks and projects • Excellent accuracy and attention to detail • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Job Responsibilities / Requirements Strong end-to-end programming experience, including SDTM, ADaM, and TLF development. Minimum 2 years of relevant experience in project and people management, including oversight of project metrics. Lead and manage a team of 20+ members. Hands-on experience in safety and efficacy programming, including writing specifications for SDTM and ADaM datasets. Experience across Clinical Phases I, II, III & IV. Therapeutic Areas: Any. Proficiency in R or Python is a plus.

Essential Function The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other functional areas as required. General areas of responsibility also include import/export programming specification development, test data creation and test data entry, import/export programming functional testing, as well as mapping specifications to support relevant data standards. Key Accountabilities Deliver best value and high-quality service. Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will: Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Interact with Sponsors as the key contact with regard to statistical programming issues. Provide technical support and advice to the internal team. Check own work in an ongoing way to ensure first-time quality. Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed. Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup. Sas, formats, Sas, etc.), tracking spreadsheets, and required documentation. Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents. Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department. Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units. Create standard macros and applications to improve the efficiency of the department. Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance. Be trained in sponsor WSOPs and disseminate knowledge to project team members as appropriate. Proactively participate in and/or lead process/quality improvement initiatives. Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required. Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas. Maintain and expand local and international regulatory knowledge within the clinical industry. Assist project teams in the resolution of problems encountered in the conduct of their daily work Provide relevant training and mentorship to staff and project teams. Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request. Develop mapping specifications for data exports in accordance with applicable standards. Skills Proficiency in SAS. Knowledge of the programming and reporting process. Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. Demonstrate ability to learn new systems and function in an evolving technical environment. Strong leadership ability. Attention to detail. Ability to successfully work together with a (virtual) team (including international teams as required) as well as independently. Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change. Business/Operational skills that include customer focus, commitment to quality management and problem solving. Good business awareness/business development skills (including financial awareness). Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial. Work effectively in a quality-focused environment. Demonstrate commitment to refine quality processes. Effective time management in order to meet daily metrics or team objectives. Shows commitment to and performs consistently high-quality work. Education Educated to degree level in a relevant discipline and/or equivalent work experience. Language Skills Competent in written and oral English. Excellent communication skills. Minimum Work Experience Relevant Clinical Trial industry experience.

Minimum experience: 10 years. We're seeking someone who brings: Extensive hands-on experience in End to End programming A strategic mindset and the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes If you're ready to take on a high-impact role with a global sponsor wed love to connect!

The ideal candidate for the Senior Statistical Programming position should have a minimum of 3-8 years of experience. You should possess a strong understanding of SAS Base/Macros/GTL and have hands-on experience in SDTM/ADAM/TLFs creation following CDISC standards. Your expertise should lie in both Base and Advance SAS programming. You will be responsible for developing complex SAS macros that can be applied across Therapeutic Areas in various studies. Additionally, your role will involve reviewing the SAS programs that have been developed. Proficiency in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components is crucial for this position. As a Senior Statistical Programmer, your primary duties will revolve around SAS programming within the pharmaceutical industry. Therefore, a Bachelor's degree in a related field is required for this full-time, permanent position. Key Skills: - SAS - SDTM - ADAM - TLF - Statistical Analysis If you meet the above requirements and are ready to take on this challenging role, we encourage you to apply using the Job Code: GO/JC/551/2025. For any queries regarding the position, you may reach out to the Recruiter, Sangeetha Tamil.,

3- 8 years of experience for Sr Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Expertise in Base and Advance SAS programming. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Location : - Bengaluru,Mumbai,Pune,Hyderabad Contact Person : - Sangeetha Tamil

Role & responsibilities: Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately definesall variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programmingdeliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Preferred candidate profile : Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. Excellent written and verbal communication skills.

Role & responsibilities: 5-8 years of experience in SDTM / ADaM / TFls. Develop and validate SDTM/ ADaM data sets, TDLs. Support Safety & efficacy Analyses Contribute to E-submission generating define.XML and ADRG / SDRG and leading clinical study Trails Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiates and establishes accurate time estimates for completion of study programming activities with internalteam members and statistical programming management and completes project programming activities within timeframe allotted. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Transfers deliverables. Performs other work-related dutiesas assigned. Minimal travel may be required Preferred candidate profile : Graduate / Post Graduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an 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.

Good to Have Skills Proficiency in CDISC standards, particularly ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model). Experience in creating and validating ADaM datasets, ensuring they are analysis-ready and compliant with regulatory requirements. Hands-on experience with efficacy analysis, including the creation of statistical analysis plans (SAPs) and mock TLFs (Tables, Listings, Figures). Soft Skills Excellent communication skills for collaborating with cross-functional teams and presenting findings. Attention to detail and strong problem-solving abilities. Ability to manage multiple projects and meet deadlines. Must Have Skills - Hands-on experience with efficacy analysis.

Minimum experience: 8 years. We're seeking someone who brings: Extensive hands-on experience in End to End programming A strategic mindset and the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes If you're ready to take on a high-impact role with a global sponsor we’d love to connect!

- Experience Required: 5+ years into clinical SAS Programming Requirements: - Strong experience in Base SAS, Advance SAS, SDTM dataset & specification generation. - Must have good experience in ADaMs, table, listing and figure creation. - Good to have study lead exposure.

Role & responsibilities JOB DESCRIPTION The Statistical Programmer I (SP I) or Statistical Programmer II (SP II) Programs all tables, listings and graphs necessary for an assigned clinical study report (CSR); Programs customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies; Writes code using Base SAS programs, SAS procedures, or standardized macros; Analyzes protocol, SAP, existing shells/templates as needed to understand structure and content of data; Performs data checks as needed, to ensure integrity and correctness of data displays; Prepares documentation for programs; Prepares documentation describing all datasets and variables within, including derived variables, and the project as a whole; Creates SAS datasets of clinical data from clinical databases; Creates status and efficacy datasets; Creates project-specific macros and formats; Loads client data from other platforms and other software packages; Prepares data to be sent to clients and as needed for other external transfers and data imports. QUALIFICATION FOR ESSENTIAL FUNCTIONS 1. Ability to communicate effectively in English, in both writing and verbal. 2. Ability to learn quickly and pay attention to details. 3. Ability to manage multiple tasks/projects, effectively prioritize and execute tasks, and make quality and on time deliveries. 4. Ability to work collaboratively, effectively, and productively in diverse organizational structures, and in interaction with dynamic clients. 5. Ability to work independently, takes ownership and strives for quality and efficiency. 6. Ability to work positively in a continually changing environment. 7. Solid/Advanced SAS skills and understanding of the concept of standardization in data, programming, and statistical reporting of trial results and its implication to drug development. EDUCATION AND EXPERIENCE REQUIRED 1. Bachelors degree, but Masters degree or above, is preferred, in Biostatistics, Computer Science, Mathematics, or a combination of education and relevant industry experiences. 2. Strong SAS programming language and good knowledge/experiences of clinical trial and drug development.

#hiring . Know anyone who might be interested? "Remote Opportunity" Veeda Lifesciences is seeking a passionate "Biostatistician II". Interested candidates can share an updated CV to mahendra.t3705@veedalifesciences.com Position Summary The Biostatistician II is responsible for collaborating with multiple Sponsors across several therapeutic areas in all phases of clinical trials and combining statistical expertise, technical knowledge on data processing and the ability to handle complex scientific/medical aspects of the study to efficiently support the Companys global clinical program. Role & responsibilities Acts under the supervision of more experienced biostatisticians of the Department, to provide statistical oversight and attend relevant project meetings Maintains and effectively communicates the status of analysis-related tasks to the Principal Biostatistician and given internal project managers of assigned studies, as appropriate Prepares Statistical Analysis Plans (including mock TFL shells) Works closely with the statistical programming team and performs statistical review of TFLs prior to Client delivery Reviews the CRF and other study specific documents, to ensure that the objectives of the study are covered Performs sample size calculation for Clinical Studies, under the supervision of more experienced biostatisticians Provides statistical input and reviews CSRs and protocols, under the supervision of more experienced biostatisticians Participates on the write-up of scientific abstracts, posters and manuscripts Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS reports for DM function.( E.g., missing pages report, reconciliation report, patient profiles etc). Key requirements: 1) SAS Programmers with a minimum of 10 years of experience in clinical SAS programming. Python is good to have skillset. 2) Min 5 years of SAS experience with good understanding of DM and clinical stake holder requirements. Additional details: Responsibilities include (but not limited to) design, development, implementation, and validation of programs created in SAS dashboard applications, to process, analyze and report clinical trial data for review by clinical study teams. Works within established frameworks and ensures high quality is built into own deliverables. Works independently for well-defined scope of work Under guidance, creates catalogue of reports to aid data cleaning activities with moderate scope and medium complexity, but not limited to: Automate manual checks. Automate reconciliation and program edit checks for TPV data to ensure quality. Create tools and repository to minimize data errors at source for collection of lab reference ranges. Program reports to identify missing pages and also detect errors at Subject level. Create reports to measure metrics that can help assess data cleaning status. Create visualizations and dashboards to identify discrepancies in EDC and TPV data. Maintain created catalogue of reports and perform updates based on ongoing changes to requirements. Provide support as required to ensure availability and performance of developed reports and dashboards for both external and internal users Responsible for completion of documentation associated with programming tasks (e.g. peer review, report specifications etc.) in compliance with applicable SOPs Proactively keeps the lead programmers updated on progress of deliveries. Contribute to implementation of cross-functional projects that are part of clinical programming roadmap.

Master s degree, equivalent, or higher in Biostatistics, mathematics, computing, or related field Minimum 8 + years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job Experience with SAS statistical software Must have experience inSDTM and ADAM and TLF Experience leading statistical programming activities in clinical research PreviousOncology experience(safety and efficacy) in pharmaceutical research or CRO setting preferred Knowledge of one or more statistical software packages (SAS preferred + R) used to conduct statistical analyses Experience withCDISC standardsand other industry guidance/dictionaries like RECIST criteria, MedDRA, WHO Drug, CTCAE etc. Good verbal and written communication Demonstrate ability to provide coaching, mentoring, and training to new hires and less-experienced colleagues.