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Job Title: Principal Programmer Statistical Programming Introduction To Role Are you ready to take on a pivotal role in statistical programmingAs a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications Your expertise will drive the creation of Tables, Listings, and Figures for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements You'll lead programming efforts, represent Clinical and Statistical Programming in meetings, and mentor fellow programmers This is your chance to integrate statistical concepts with SAS Programming efficiently and effectively! Accountabilities Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards, Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications, Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP, Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications, Supervise/manage external vendors and contract programmers, Oversee progress of programming activities, Review, maintain, and approve protocol-specific documents as necessary, Provide guidance and mentoring to peer and junior-level Programmers, Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies, Contribute ideas and thoughts towards the optimization of standard operating procedures, Lead team meetings when appropriate, Any other activities as required, Essential Skills/Experience Bachelors Degree (Minimum) or Masters Degree (Preferred) in Biostatistics, Statistics or another related discipline Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry, Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs, Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT, Knowledge of SAS/Graph, and SAS/SQL Knowledge of: SDTM and ADaM Relational Databases, Good Clinical Practices, Good Programming Practices, 21CFR Part 11 Standards, Integrated Summary Safety/Efficacy Analyses, Safety data and Coding Dictionaries (MedDRA and WHODD), ICH eCTD format, At AstraZeneca, we play an essential role in helping patients who need it the most Our high exposure roles allow us to shape end deliverables while embracing global opportunities across all Therapy Areas With a restless drive for improvement, we foster an inspiring learning environment where every setback is a chance to innovate Our courageous team speaks up, shares opinions, and makes bold decisions that could change patients' lives We combine specialist knowledge with curiosity, always searching for better ways to achieve the best results Here, dedication and motivation are key as we navigate unknowns with resilience, Ready to make an impactApply now to join our dynamic team! Date Posted 11-Jul-2025 Closing Date 30-Jul-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law Alexion provides reasonable accommodations to meet the needs of candidates and employees To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion Alexion participates in E-Verify, Show

The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management. The preferred candidate for this position should hold certification in clinical data management (like CCDM) and possess knowledge of CRF design, MS Project, and analytical capabilities. Familiarity with CDISC standards and data interchange formats such as SDTM and ADaM is beneficial. Basic knowledge of regulatory guidelines like FDA/CFR, ICH/GCP, understanding of data privacy and protection regulations (e.g., GDPR), and effective communication and interpersonal skills are essential to collaborate effectively with other teams. This role offers the opportunity to contribute to the advancement of clinical data management practices and maintain high standards of data quality in compliance with regulations and protocols.,

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 will be crucial, along with efficient debugging and utilization of standard macros. If you have experience with integrated summaries (ISS/ISE), it is considered a plus. The ideal candidate should possess 6 to 8 years of relevant experience in statistical programming, with a minimum of 3 years of hands-on experience in R programming. A strong working knowledge of CDISC standards such as SDTM, ADaM, and TLF is essential, along with exposure to efficacy analysis. Senior-level profiles should have experience in handling studies at the study level. Preferred skills for this role include familiarity with the CRT package (Trial Data Domain), previous involvement in ISS and ISE, experience in an FSP environment, and proficiency in standard macro debugging and utilization. In return, we offer a bootstrapped and financially stable environment with an above-industry renumeration package. Additional compensation is tied to Renewal and Pilot Project Execution, along with lucrative business development incentives. Our organization provides opportunities for firm building and holistic professional development, emphasizing empathy, excellence, and results. We believe in mentoring and nurturing our team members, with a continuous focus on learning and growth.,

1. Advanced skills in statistical and biostatistical analysis 2. Ability to communicate effectively in the English language in person, by phone and in writing 3. Designs, plans, and execute biostatistical components of clinical studies. 4. Uses statistical methodology to conduct studies and prepares statistical components of protocols. 5. Responsible for the statistical components of reports. 6. Develops statistical analysis plans and reporting specifications for clinical studies. 7. Reviews reports and underpins the results with statistical expertise. 8. Prepares and annotates shell data displays 9. Analyzes and interprets results from clinical studies using sound statistical methodology. 10. Contributes to the development of statistical analysis plans including TFL shells. 11. Performs statistical analyses under the guidance of other statisticians or independently for simple clinical studies. 12. Assists with the review of TFLs, tabulation datasets, and derived datasets. 13. Advanced computer skills and practical knowledge of MS Word, Excel, PowerPoint, and project management software.

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.,

Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

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

As a Senior Clinical Data Analyst, you will be responsible for creating Data Management Plans (DMP), eCasebook Guidelines (eCCGs), Edit Check Specifications, Data Review Listing Specifications, and other set-up documents. You will also perform User Acceptance Testing (UAT) and review the Electronic Data Capture (EDC) database to ensure data consistency and completeness. Your duties will include Listings Review, Query Management, managing Serious Adverse Events (SAE) and external vendor data reconciliation, analyzing data trends, and generating reports. Additionally, you will be involved in User Account Management, Study Metrics, Quality Control (QC), and EDC Archival. In the role of Senior Statistical Programmer, your responsibilities will include developing, validating, and maintaining programs and tools to generate reports and listings for data review. You will create data transfer specifications, train and mentor other programmers, and establish programming specifications. It will be vital to maintain all necessary programming documentation while adhering to quality and industry standards. You will act as a Subject Matter Expert (SME) for technical inquiries, monitor tasks that may fall within or outside the project scope, and develop, validate, deploy, and manage EDC study builds. Your expertise will be required in crafting tools and macros to enhance quality and efficiency, and your proficiency with industry data standards such as CDASH, SDTM, ADaM, etc., will be crucial. To qualify for this position, you should possess a minimum of 3 to 4 years of relevant experience in the field.,

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.

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 expertise for various therapeutic areas. Qualifications Minimum 5 years of experience for Senior and 10 years of experience for Principal role in Statistical Programming for clinical trails using SAS Experience on R (especially admiral package) is mandatory as per the client request Data Management and Macro skills Experience in CDISC Data Standardization (SDTMs), ADaM and TLFs Experience in ADaM, TLFs Experience in creating Graphs using SAS or R Experience in (early phase studies, ideally PK/PD, biomarker) or HIV Therapeutic Area is desired. Ability to work independently and collaboratively Strong analytical and problem-solving skills Excellent communication and organizational skills Bachelor's or Master's degree in Statistics, Computer Science, or related field Willing to work in UK/US time zones and the job is based in India How To Apply If you met all the mentioned qualifications above, please send your resumes to info@cpvia.com,

#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

Company Overview Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented Lead Statistical Programmer to join our team and contribute to our mission. Position Overview The Lead Statistical Programmer will bring statistical programming and clinical expertise to the creation of SDTM and AdaM domains, as well as tabulations, graphics and listings derived from clinical trial data. Responsibilities include programming Data Management Listings in accordance with sponsor requirements, preparing, documenting and testing necessary programs and ensuring that programming code adheres to regulatory and company standards. The role also involves performing quality assurance on work done by others, supporting production activities and assisting in training new employees. Primary Responsibilities Provides data to clients (internal and external) in functional format by: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Developing SAS programs that convert data from EDC to protocol-specific SAS datasets in accordance with customer specifications Assist with the creation of SAS-related project programming and validation documentation Assist with the creation of SAS macro and format libraries Ensures the quality of our client's data and data export by Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents Developing and implementing new CDM systems and enhancements to current CDM systems Understand, create, and communicate information about creating CDISC-compliant datasets Create documentation related to the generation of customer specific SAS datasets Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs Ensures project timelines as they relate to Clinical Data Management operations by Assessing and assigning target dates for project timelines in conjunction with manager Adhering to target dates for project timelines Communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of current issues Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by: Coordinating activities of the Clinical Programming department with related activities of other departments (operations programming, study QA, PM and DM) to ensure efficiency Evaluating current procedures and work instructions for accomplishing department objectives in order to develop and implement improved procedures Assisting the training department with the development and maintenance of Clinical Programming training materials Secondary Responsibilities Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned and deemed necessary Maintains Technical Knowledge by Attending and participating in applicable company sponsored training Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Reviewing and providing recommendations to management on operational procedures, and participating in process improvement initiatives Qualifications Education Bachelors degree in computer science, design or related field required Educational background in human-computer nteraction, usability, user-centered design, user experience, information design, applied psychology, cognitive science, human factors, informatics, computer science, or other design/applied science fields is a plus. Experience 8+ Years of experience, SAS programming experience in pharmaceutical related industry - Required 5+ Years of experience, Experience working with CDISC, SQL, and Relational Databases - Required 3+ Years of experience, Understanding of database organization and how to extract data to generate listings and reports - Required Additional skill set Ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Working conditions Travel: 5-20% Lifting: 0-25 lbs Other: Computer work for long periods of time THIS POSITION DESCRIPTION SHOULD NOT BE DEEMED ALL INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.

Bulk Hiring - Clinical SAS Programmer Mode: WFH-Permanent Salary:No Bar Skills: Statistical Programming /SAS Programming, SDTM, ADaM, TLF /TLG, Efficacy. Qualification: PG-degree in statistics, computing, life science-related field B.E/B.Tech.

Position Summary: The Clinical Data Manager II is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements. The Clinical Data Manager II is able to assist and lead data management team and provide support to Lead Clinical Data Manager, develop project documentation, project plans, EDC system setup, data review and validation processes. Role & responsibilities Implements, monitors and supervises data management activities within assigned clinical trials, i.e., is responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans and Data Management Plans Provides the study status updates with respect to data, using standard reports (CPT, data entry, queries, SDV, safety reconciliation etc.) and communicates efficiently the status to the team Creates and executes data quality checks throughout the study conduct Day to day responsibilities (under the guidance of senior personnel) may include but are not limited to: data review, open/close queries in the eCRF, medical coding, central lab data reconciliation, PK data reconciliation, ad-hoc data reports creation, User Acceptance Testing (UAT) of internal and external electronic Data Capture systems Provides support to the resolution of issues and inputs ideas to help resolve issues and contribute to continuous improvement Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection Key competencies: Excellent knowledge of CDISC/SDTM/ADAM specifications Excellent IT skills and MS Office command Ability and willingness to operate independently Ability to communicate effectively both verbally and in writing Ability to manage multiple and varied tasks and prioritize workload with attention to detail Demonstrate quality driven mindset while performing any of the assigned tasks Excellent knowledge of ICH/GCP, 21 CFR Part 11, guidelines and regulations, particularly those relevant to clinical data management Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice Professional Experience Requirements: Required: 8 Years experience as Clinical Data Manager Phase I -III Studies Desirable: Experience working with Medidata Rave Education Requirements: Required: BSc in Statistics, Biostatistics, Mathematics, Data Science or other applied sciences relevant field, life science, pharmacy or related subject or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) Desirable: MSc in one of the above fields

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.

Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in FSP.

6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.