14 Cdisc Standards Jobs

You are a highly skilled Senior SAS Programmer sought to support statistical programming activities for clinical trials. Your responsibilities include end-to-end SAS programming for analysis and reporting, ensuring regulatory compliance, data standards, and high-quality deliverables. Your expertise in efficacy analysis, SDTM and ADaM generation, and TLF programming is crucial for this role. You will manipulate, analyze, and report clinical trial data using SAS, generating and validating SDTM and ADaM datasets in adherence to CDISC standards. Additionally, you will create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Your role involves developing complex ad-hoc reports from raw clinical data and applying a deep understanding of efficacy analyses and clinical endpoints. Contribution to the preparation and review of submission documents and eCRTs is expected, as well as production programming and quality control to ensure accuracy and consistency. As a team player, you will commit to quality and meeting project deadlines, remaining adaptable and flexible in a fast-paced clinical environment. Qualifications required include a Bachelors or Masters degree in Life Sciences, Statistics, Computer Science, or a related field, along with 6+ years of hands-on experience in clinical trial programming using SAS. Proficiency in CDISC standards, Base SAS, SAS Macros, SAS/STAT, and SAS/GRAPH is essential. Experience in generating datasets and outputs for regulatory submissions and familiarity with eCTD standards are preferred. Strong attention to detail and analytical problem-solving skills are necessary for this role. Join a collaborative team environment where your expertise in clinical data programming directly contributes to advancing global healthcare. Precision, integrity, and innovation are valued in every project undertaken.,

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. You will follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines. This position may involve database development and testing, as well as additional data management activities. Key responsibilities of the role: - Support the Lead DM as a backup or team member, ensuring continuity, responsiveness, and timely task completion - Perform data entry for paper-CRF studies and ensure quality control of data entry - Provide input into timelines, assess resource needs for projects, and ensure clinical data management deadlines are met with quality - Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback - Assist in building clinical databases and conduct database build UAT - Specify requirements for edit check types and maintain data management documentation - Train clinical research personnel on study-specific items as needed - Review and query clinical trial data according to the Data Management Plan - Perform medical coding of medical terms for logic and consistency - Assist with coordinating SAE/AE reconciliation and liaising with third-party vendors - Assist with SAS programming and quality control of SAS programs - Identify and troubleshoot operational problems and provide feedback on protocols and reports - Participate in the development and maintenance of SOPs related to data management - Communicate with study sponsors, vendors, and project teams regarding data issues - Present software demonstrations/trainings and participate in project meetings - Perform other assigned duties. Qualifications: - Minimum 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - Proficiency in Microsoft Office tools - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development and data management practices Preferred qualifications: - Experience in a clinical, scientific, or healthcare discipline - Medical coding knowledge (MedDRA and WHODrug) - Understanding of CDISC standards - Oncology and/or Orphan Drug therapeutic experience Skills: - Strong knowledge of ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies: - Motivates project team members and focuses on continuous improvement - Resolves project-related problems and prioritizes workload effectively - Demonstrates self-motivation and professionalism - Works well independently and in a team environment Precision for Medicine is a precision medicine CRO dedicated to advancing the science of precision medicine across various therapeutic areas. All data provided during the application process will be handled in accordance with the Privacy Policy. Applicants with disabilities requiring accommodations can contact Precision Medicine Group for assistance. Note: Precision for Medicine warns applicants about potential fraudulent offers and emphasizes that all job offers will involve communication with the recruiting team, hiring managers, and a formal interview process.,

The Senior/Principal Clinical Database Manager is responsible for the design, development, testing, implementation, maintenance, and support of clinical databases and applications. You will interface directly with the internal team, EDC vendor, clients, and third-party vendors to gather requirements and provide status updates. Providing operational and technical training to end users and junior staff is a key aspect of this role. Additionally, you may play a lead role in internal software projects that require specialized programming and/or scripting. To be considered for this position, you must have experience in developing and customizing clinical data management databases in a clinical, scientific, or health care discipline. A combination of related experience and a Bachelor's degree is required. You should also be a Medidata Rave EDC Certified Study Builder with experience in Rave API integration and Advanced Custom Function programming. Proficiency in Microsoft Office applications, handling various clinical research tasks, excellent organizational and communication skills, and a professional command of the English language are essential for this role. Experience in Object-Oriented Programming, scripting languages, SAS, R, SQL, CDISC standards, and clinical database management systems is also necessary. Broad knowledge of drug, device, and/or biologic development, effective data management practices, strong leadership, and interpersonal skills are key qualifications. Preferred qualifications include experience in Oncology and/or Orphan Drug therapeutic areas, proficiency in Base SAS, SAS/STAT, SAS/ACCESS software, SAS Macro programming language, advanced database management experience, and Veeva set-up experience. If you require a reasonable accommodation to complete the application process or need an alternative method for applying due to a disability, please contact Precision Medicine Group. Please be aware of potential fraudulent employment offers and note that our organization follows a formal interview process before extending any job offers.,

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.,

As a Senior SAS Programmer at our rapidly growing corporate activities in India, Mumbai, you will play a crucial role in our Biostatistics team. You will have the opportunity to work alongside a dedicated team to complete tasks and projects essential for the company's success. If you are looking for a challenging career where you can utilize your expertise and further develop your skills, this position offers an exciting opportunity for professional growth. Your responsibilities will include proposing and developing specifications for new projects, leading project teams, and writing SAS programs to create analysis datasets, tables, listings, and figures. You will be responsible for programming, validating, and maintaining mapped databases, as well as implementing edit checks for external data. Additionally, you will contribute to setting up, validating, and maintaining mapped databases, integrating external data with edit checks, and writing quality programs independently. To qualify for this role, you should hold a Bachelor's or Master's Degree in math, Statistics, health informatics, data science, computer science, or a life sciences field. With at least 5 years of experience in SAS programming, you should have excellent knowledge of CDISC standards and possess a SAS Certification. A thorough understanding of the pharmaceutical industry and Federal Regulations related to electronic records is essential. Strong analytical, written, and oral communication skills, along with proficiency in English, are required for this position. Medpace is a full-service clinical contract research organization (CRO) dedicated to providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. With headquarters in Cincinnati, Ohio, and a global presence in over 40 countries, we leverage local regulatory and therapeutic expertise across various key areas such as oncology, cardiology, metabolic disease, and more. At Medpace, we value our employees and offer a flexible work environment, competitive compensation and benefits packages, structured career paths for professional growth, company-sponsored employee appreciation events, and health and wellness initiatives. We have been recognized by Forbes as one of America's Most Successful Midsize Companies and have received CRO Leadership Awards for our expertise, quality, and reliability. If you are interested in joining our team, a Medpace representative will review your qualifications and reach out with further details. We invite you to be part of a company that makes a real difference in the lives of patients and families worldwide. Experience the rewards of working with us and contribute to improving healthcare outcomes for future generations.,

The ideal candidate for the Biostatistician role should possess a Master's degree in Statistics or equivalent. A Ph.D. in Statistics or equivalent combined with 6 years of industry-related experience is also a preferred qualification. With at least 9+ years of experience, the candidate must demonstrate a deep understanding of statistical and clinical trials methodology as it pertains to clinical development. As a Biostatistician, you will be an integral part of cross-functional development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your role will involve collaborating with various stakeholders such as the GBDS Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Your responsibilities will include driving the selection of optimal study designs, data collection methods, and analytic approaches. You will be expected to provide strategic and scientific input at the indication/protocol/integrated analysis level to enhance the understanding of the asset being studied and improve development decisions. In addition to your statistical expertise, you will need to develop a broad understanding of the clinical, regulatory, and commercial landscape by researching medical literature and regulatory documents. You will be responsible for preparing the development strategy to facilitate the effective and safe utilization of the product. Furthermore, you must possess excellent communication skills to effectively collaborate with clinical and regulatory partners, external opinion leaders, and other team members. Your role will involve authoring or reviewing various study-level documents such as protocol synopsis, statistical analysis plan, clinical study reports, and publications. As a seasoned Biostatistician, you will be expected to lead the development and execution of statistical aspects for multiple complex studies independently. You will also play a key role in filing activities, including planning and executing integrated analyses. Your ability to defend protocols and Statistical Analysis Plans (SAPs) during reviews and provide independent assessments will be crucial in this role. Overall, your contributions as a Biostatistician will significantly impact the success of clinical trials, regulatory submissions, and market access strategies. Your dedication to upholding quality standards, adherence to processes and SOPs, and continuous learning of applied statistical methodology will be key to your success in this role.,

You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user requirements documents, functional specifications, and testing scripts - Interacting with end-users to create specifications and work with programmers for successful delivery - Offering quantitative analytical support to global program teams and assisting in analyzing reports - Supporting the planning, execution, and close-out of Clinical Programs/Trials - Collating and delivering analytics reports for critical decision-making purposes - Maintaining appropriate documentation and working with internal SMEs and key stakeholders to analyze clinical program/trial operational data - Providing training to end-users on the best use of various data review tools - Programming reports of varying complexity within clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R - Demonstrating good knowledge of Novartis Clinical Data Standards for creating report specifications or outputs - Supporting special projects of limited scope, both clinical and non-clinical - Offering study-level expertise and involvement in CTTs - Leading or supporting special projects across various responsibilities, such as systems issues, processes, user support, and training Your performance will be evaluated based on: - Quality and timeliness of deliverables - Revisions to deliverables due to logic or programming errors - Customer feedback and satisfaction To be successful in this role, you should have: - At least 5-7 years of experience in clinical review, reporting programming, business analytics, or clinical trial setup in the pharmaceutical, CRO, or Life Science industry - Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R) - Familiarity with Data Review and/or Business Intelligence tools (e.g., Spotfire, JReview) - Understanding of clinical data management systems and relational databases applied to clinical trials - Attention to detail, quality, time management, and customer focus - Ability to communicate technical concepts to non-technical users - Strong verbal and written communication skills for global collaboration - Knowledge of Drug Development Process, ICHGCP, CDISC standards, and Health Authority guidelines - Capability to train and supervise new or less experienced associates Novartis offers a supportive community of smart, passionate individuals dedicated to making a difference in patients" lives. If you are ready to contribute to breakthroughs that change lives, join us in creating a brighter future together. For more information about Novartis and to explore career opportunities, visit: https://www.novartis.com/about/strategy/people-and-culture If you are interested in staying connected with Novartis for future career opportunities, sign up for our talent community: https://talentnetwork.novartis.com/network To learn about the benefits and rewards of working at Novartis, read our handbook: https://www.novartis.com/careers/benefits-rewards Novartis is committed to fostering an inclusive work environment and diverse teams that reflect the patients and communities we serve. If you require accommodation due to a disability, please contact [email protected] with your request and contact information, including the job requisition number.,

The Clinical Database Programmer (CDP) within the Global Clinical Data Management (GCDM) department is responsible for managing Clinical Data Programming activities. Your role involves ensuring the timely creation, validation, testing, implementation, and maintenance of databases required for all assigned projects. You will analyze study protocols and project requirements, identify data quality rules, and design data entry interfaces in compliance with study protocols, Data Management Plans (DMP), Standard Operating Procedures (SOP), and relevant regulatory requirements and standards. You will be responsible for deploying complete, accurate, and efficient clinical study databases to support Data Management and Data processing. This includes supporting the preparation, transfer, and integration of clinical data from internal and external sources into the study database. Additionally, you will provide clinical study data in various formats to critical project stakeholders, ensuring high-quality deliverables and active participation in project teams to meet standards. Your role will involve data exchange with external project stakeholders, such as third-party vendors and Safety/Independent Data Monitoring Committees. You will provide ongoing end-user support to project teams, including setting up and supporting data review and reporting tools required by various stakeholders. Collaboration with SAS programmers, Clinical, Medical, Pharmacovigilance, Regulatory Affairs, and the Study Management Team is essential to ensure technical expertise and programming support for projects and data management staff. Furthermore, you will communicate project status and key issues to management, assist in developing new Data Systems programming procedures, and stay informed about technological advancements to maximize their use in data management. Mentoring, training, and work delegation will also be part of your responsibilities, along with supporting the standardization of CRF and eCRF modules, data quality rules, data structures, dictionaries, and CDISC standards. The ideal candidate for this role should hold a Bachelor's degree in a Life Science, Nursing, Computer Science, or related discipline. A minimum of 8-10 years of clinical data programming experience, including proficiency with clinical data programming tools and applications, is preferred. Experience in leading clinical programming efforts across global studies is advantageous. This position is based in Gurugram, HR, and you will report to the Clinical Database Programming Lead (CDPL).,

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent, you will lead and coordinate clinical programming activities and maintain clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards, and regulatory requirements. You will be part of a small but nimble global team. Credibility, quality, and collaborations are the key pillars that drive this team. We are looking for you to come with an innovative and can-do approach where you can have a quick impact. In this role, your key tasks will include designing, building, testing, and releasing clinical databases to the production environment, including study design specifications, User's Acceptance Test (UAT) test cases, and database configuration settings in support of database set-up and edit checks programming. You will work with SAS and EDC programming, review electronic Case Report Form (eCRF) completion guidelines, develop and/or validate SAS programs for metric reporting, data review listings, data import, and data export set-up. You will also support the application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, review and adhere to the requirements of study-specific data management documents & plans, actively contribute/participate in study team, departmental meetings, sponsor meetings, and use an analytical approach to problem-solving. Collaborating with peers, programmers, study teams to clarify specifications, and using expanded technical skills to meet evolving project needs is also a key responsibility. Additionally, maintaining a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings, researching and proposing initiatives for improving efficiency, developing and delivering applicable DM departmental trainings, drafting and contributing as a Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes, and procedures within the Quality Management System are essential tasks. To be successful, you will possess a minimum of 2-5 years of relevant work experience in a clinical research and/or drug development organization combined with a degree in Life science and experience in SAS and EDC programming. Computer Science, healthcare, and/or related field degree. You will be a great addition to the team when you are open and transparent, work well together and have a solution-focused approach. Good knowledge of ICH-GCP(R2), GDPR/HIPPA, and applicable (local) regulatory requirements, good understanding of clinical data management processes and experience with tools and systems for managing clinical studies, solid understanding and hands-on experience with CDISC standards (i.e. CDASH, TAUGs, and SDTM models), strong programming SAS skills with proficiency in Electronic Data Capture (EDC) systems, data reporting, and programming languages such as PL/SQL, SAS, and comparable fields, ability to work in a fast-paced challenging environment of a growing company are important traits and behaviors we are looking for. Benefits of working at Allucent include a comprehensive benefits package per location, competitive salaries per location, departmental Study/Training Budget for furthering professional development, flexible working hours (within reason), opportunity for remote/office-based* working depending on location, leadership and mentoring opportunities, participation in our enriching Buddy Program as a new or existing employee, internal growth opportunities and career progression, financially rewarding internal employee referral program, access to online soft-skills and technical training via GoodHabitz and internal platforms, eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects, eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees. *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within a reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.",

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.,

You will be a valued member of our clinical research team as a Statistical Programmer, where your primary responsibility will be to program, validate, and deliver statistical outputs for clinical trials. In this role, you will play a crucial part in ensuring compliance with regulatory standards and industry best practices. Your key responsibilities will include developing and maintaining SAS programs for clinical trial data processing, analysis, and reporting. You will be required to map clinical trial data to CDISC standards (SDTM and ADaM) to ensure compliance with regulatory requirements. Creating and maintaining analysis datasets following CDISC implementation guidelines will also be a part of your daily tasks. Additionally, you will perform data validation and quality control checks to uphold data integrity. Documentation and compliance will be another important aspect of your role. Your tasks will involve generating and maintaining CDISC documentation, which includes define.xml files, reviewer's guides, and annotated case report forms (aCRF). Conducting Pinnacle21 validation checks, resolving compliance issues, and ensuring that all deliverables meet regulatory submission standards will be essential. Maintaining comprehensive programming documentation and version control will also be part of your responsibilities. You will also be responsible for producing Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans (SAP) and collaborating with biostatisticians to implement complex statistical analyses. Supporting clinical study reports and regulatory submissions, as well as performing ad-hoc analyses as requested by clinical teams, will be part of your statistical analysis and reporting responsibilities. Collaboration is key in our team, and you will work closely with clinical data management, biostatistics, and regulatory affairs teams. Your involvement in project meetings, providing technical expertise, supporting timeline planning, and deliverable tracking will be crucial. Additionally, you will mentor junior programmers and provide them with technical guidance. To excel in this role, you will need a minimum of 3+ years of experience as a statistical programmer in clinical research or the pharmaceutical industry. Advanced SAS programming skills, including expertise in Base SAS, SAS/STAT, SAS/GRAPH, and SAS Macro language, are required. A strong understanding of clinical trials, CDISC standards, and experience with CDISC documentation are essential. Soft skills such as excellent communication, problem-solving mentality, attention to detail, and effective team collaboration will also be important. Preferred qualifications include experience with Real-World Data (RWD), Pharmacokinetic (PK) calculations, R programming, and knowledge of other statistical software packages. A Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field is required, while an advanced degree is preferred but not mandatory if you have relevant experience. This position offers a competitive salary, comprehensive benefits package, professional development and training opportunities, a collaborative work environment, and career advancement opportunities within our growing organization. Join us and contribute meaningfully to clinical research while developing expertise in regulatory compliance and industry best practices.,

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

Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with U.S.-based Biometrics leadership to align deliverables and timelines across global development programs. Support biostatistical leadership by overseeing the development and validation of Statistical Analysis Plans (SAPs), as well as generation of tables, listings, and figures (TLFs) for clinical study reports (CSRs). Supervise the creation and validation of SDTM and ADaM datasets in compliance with CDISC standards. Collaborate with Clinical Data Management leads (where applicable) to ensure effective Clinical Data Management practices and data quality. Ensure alignment of Biometrics activities with overall project goals, timelines, and regulatory requirements. Monitor workload, resourcing, and productivity across the India Biometrics team. Facilitate communication and integration across functional teams (Biostatistics, Statistical Programming & Clinical Data Management). Mentor and support the development of team members across both disciplines. Stay current with industry standards and regulatory expectations in Biostatistics, Statistical Programming , CDISC, and Clinical Data Management practices. Qualifications: Masters degree in Biostatistics, Statistics, Clinical Data Science, Life Sciences, or a related field. 15+ years of experience in the pharmaceutical, biotechnology, or CRO industry within biostatistics, statistical programming, and/or Clinical Data Management. Strong working knowledge of clinical trial processes and relevant regulatory requirements (e.g., GCP, CDISC, BLA/NDA submissions). Hands-on expertise Biometrics with all three functions (Biostatistics, Statistical Programming & Clinical Data Management). Ability to lead and manage cross-functional technical teams. Strong project management, problem-solving, and interpersonal communication skills. Proficiency in relevant tools and platforms (e.g., SAS, R, EDC systems, CDMS, Veeva eTMF, Quality Docs, and eQMS platforms). Experience working in a global team structure and across time zones. Proven track record of leading and managing cross-functional biometrics teams, with experience in overseeing the development and validation of statistical analysis plans and clinical study reports. Experience with CDISC standards (SDTM and ADaM) and proficiency in statistical programming languages (e.g., SAS, R). Familiarity with electronic data capture (EDC) systems and Clinical Data Management systems, with a strong understanding of data integrity and quality practices. Demonstrated ability to manage multiple projects simultaneously in a fast-paced environment, with excellent organizational and problem-solving skills. Strong interpersonal and communication skills, with the ability to collaborate effectively with global teams and senior leadership. Commitment to continuous professional development and staying current with industry trends and best practices. Experience with Microsoft-based applications and ability to learn internal applications/systems, including Veeva platforms such as Quality Docs, eTMF, and CDMS. Experience with eQMS systems is a plus. Working conditions: This position operates in an office setting. The job may require an incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.