Description Finance Specialist, Saama develop life science solutions that accelerate clinical and commercial development. Today, more than 50 biotech companies—including many of the top 20 pharmaceutical companies—use our award-winning Life Science Analytics Cloud (LSAC) platform to accelerate more than 1,500 studies, including the clinical trial that led to the world’s first COVID-19 vaccine. Our rich applications facilitate unprecedented and authoritative oversight and automation of comprehensive clinical research data, enabling companies to file New Drug Applications (NDAs) more efficiently and bring treatments to patients sooner. Key Relationships All project team members onsite in USA and globally Executive Leadership Team Product teams Engineering Teams Operations support teams. Client Relationships Investors What We Value Integrity: doing the right thing Solutions: solving core, complex business challenges Collaboration: working as one team Innovation: changing the game Transparency: communicating openly Enjoy & Celebrate: having fun. Competencies Results-oriented and a self-starter who enjoys a challenge and needs minimal support and direction. Takes initiative, challenges status quo. Learns quickly; takes smart risks & experiments. Consulting skills; finds key requirements in dynamic environments. Positive Attitude, Communication & Influence skills. Able to communicate effectively and credibly with clients, and other team members. Effective in both written and spoken communication. Stays the course despite challenges & setbacks. Knowledge, Skills & Abilities Excellent "firsthand" accounting skills Excellent verbal and written communication skills Excellent organizational skills and diligence Excellent time management skills with a proven ability to meet deadlines; proven experience in a fast-paced PE-backed environment is desirable. Proficient with Microsoft Office Suite (Highly Proficient in Excel & Advanced Excel Skills) or related software and specialized accounting software used by the organization. Experience with NetSuite would be beneficial. What You’ll Do The finance specialist role is a critical role recommending Business & Functional Leaders based on Insights from Business Trends & Operational Performance. S/he will be able to make recommendations based on models Metrics imperative for the financial planning and analysis for the business. S/he will oversee forecasting future revenues and expenditure to establish cost structures and determine capital budgeting for projects. S/he is also responsible for keeping track of our financial plan - analyzing the project performance, calculating variances between those forecasts and actuals and tracking down and explaining the causes of these variances. Works cross-functionally with sales, operations, and finance to resolve issues related to revenue, costs, values and billing. Recognizes revenue, generates forecasts, and performs analysis for Projects. Performs cash flow and variance analysis for assigned projects. Prepares accurate project budgets. Supplies financial guidance to operations management and other staff. Coordinates with support staff to ensure sponsors are invoiced in a timely and accurate manner. Leads and takes part in the analysis of cost assignments, ensuring all assigned projects adhere to accepted cost accounting standards. Leads review and delivery of /external reporting. Tracks and maintains project information and budgets within the project accounting system. Performs financial and scope review for modifications. Serves as a mentor and lead for team members. Makes recommendations for process improvements and takes part in special projects as assigned. Education and Work Experience Bachelors or Masters in Accounting 7-10 years of experience in similar role. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment, including but not limited to, computers, phones, and photocopiers. Physical Demands This position requires the frequent and repetitive use of a computer, keyboard, and mouse. Hand and finger dexterity is required. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. EEO Equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training. Show more Show less

Description JD: Data Manager, Clinical Data Management 10-15 years industry experience Do you possess a mindset to accelerate Clinical Trials using Data and Analytics, do you believe in extreme disruption of the clinical data management and clinical operations process? If yes, Saama is looking out to hire you as we believe it should not take this long to get Drugs out to Market, we believe data and analytics powered by Machine Learning and Artificial Intelligence if put to proper use within Clinical Operations and Data Management organizations can bring significant time and outcome savings. We have re-imagined data-management processes and helped organizations significantly bring down the time it takes to lock a database by up to 95% for Vaccine studies, we don’t want to stop here, we want to recognize process inefficiencies in clinical operations and data management and disrupt them. We are firm believers in re-imagining data management and analytics, what we have done so far is just scratching the surface, a lot more has to be done with you on our team leading some of these transformational initiatives. Product Owner acts as Data Management SME and serves as the main point of contact for customers to implement clinical solutions. You will work closely with Clinical trial sponsors, CROs at the executive and study team level to deliver Saama solutions to our customers. Responsibilities Drive customer implementations to successful launch by providing data management inputs wherever necessary. Work with implementation resources, product, and engineering teams onshore and offshore to deliver innovative solutions to customers. Consult with business leaders to develop and understand the complex and diverse data management needs required for the project. Understand the role of the project in the clinical landscape and determine how changing business needs will affect the project. Collaborate with the customer and internal resources to understand usage and adoption trends and impact increased application use. Partner with Business development and customer success managers to implement solutions, estimate effort and help set customer expectations. Partner with Product Management to help align real-world customer feedback with the product roadmap. Perform the industry research to identify clinical development needs. Requirements Bachelor or master’s degree in computer science or life science related discipline with IT/CRO/Pharma experience. Experience working with EDC, IRT systems and integrations, third party data handling and other clinical systems implementation. Experience in Clean patient tracker, data review, missing pages, data quality checks, 3rd party data reconciliation and use of business intelligence tools like Cognos, Oracle, BI, Tableau, Spotfire, QlikView, Informatica. Familiar with clinical trial data and related workflows. Good understanding of CDISC standards (CDASH, SDTM) and data mappings/transformations. Programming knowledge in SQL or SAS desired. Excellent understanding of common industry standard business practices related to clinical trials (study set up, study conduct, clinical operations process, data management review and reporting). Excellent at translating customer business requirements into enterprise solutions. Proven track record of driving customer success and operating at the executive and department levels within complex customer environments. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment, including but not limited to, computers, phones, and photocopiers. Physical Demands This position requires the frequent and repetitive use of a computer, keyboard, and mouse. Hand and finger dexterity is required. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. EEO Saama Technologies, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training. Show more Show less

Description Statistical Programmer – L2 Job Summary Statistical Programmer reports to Principal Statistical programmer 3/ Lead, Statistical Programming (L4 (3) or M1), is responsible to work independently on the most of the Mapping activities (SDTM/Client specific mappings) which are simple and medium complex for assigned client in the given environment for the standard domains. Understanding clinical domain, mapping logic, data issues is a part of this role. Learning the product/system/mechanism to be used for SDTM mapping is a part of this role. Knowledge, Skills & Abilities Clinical Domain knowledge Familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package) SAS Programming (Experience up to 2 years) Python Programming will be an added advantage R Programming will be an added advantage Good Communication skills, learning attitude and good team player Education And Work Experience Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute. Total experience is between 2 - 4 years Responsibilities Ability to pick up multiple tools/technologies on the job. Import and Export raw data Contribute to Mapping specifications Utilize SAS/R programming/Python programming skills for clinical trial study submissions Develop programs identifying data issues and reporting them to the appropriate team Utilize appropriate guidelines to build CDISC/regulatory compliant datasets Understand CRF annotations and check for consistency with raw data Ability to debug custom functions/SAS Macros and fix issues Good understanding of clinical data and domain Follow Client Processes and SOPs Assist senior team members in quality control processes Assist senior team members with team metrics Communicate with an internal team to create deliverables for pharmaceutical and CRO clients Work in tandem with Biostatistics and Data Management members on clinical projects Communicate with programming and statistics leads Make sure you are compliant with company policies/SOPs. About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com. Show more Show less

Description Qualification: Graduation or any equivalent qualification from a reputed institute NCG Trained on any ETL/ Reporting / Cloud computing tool Trained in writing complex SQL and doing data analysis Trained in Oracle SQL and PL/SQL Trained with Stored Procedures Trained in on UNIX commands Knowledge in Tableau will be value add Show more Show less

Description QVA 1 Saama Technologies, LLC Position Overview This position is responsible for defining and executing the validation test strategy, driving continuous improvement for quality assurance-related activities, and ensuring products meet quality standards. The Quality Validation Analyst (QVA) 1 works closely with product management, development, and quality management within Saama business lines to establish and ensure that Saama’s products and services are validated under the established product lifecycle and applicable regulations. The QVA 1 is responsible for product testing, product implementation, and documentation tasks. Key Relationships Information Technology Product Management Research & Development Quality management organization Business Teams Operations What We Value Integrity: doing the right thing Solutions: solving core, complex business challenges Collaboration: working as one team Innovation: changing the game Transparency: communicating openly Enjoy & Celebrate: having fun Key Responsibilities  Ensures compliance with regulations (e.g., FDA, GDPR) and ICH guidelines regarding product development, testing, and implementation.  Ensure that internal Verification & Validation testing of designated products is completed per applicable procedures and industry standards.  Collaborates on authoring test cases based on the defined intended use  Participates in Risk Management throughout the product life cycle, incl. production and post- release.  Executes validation test cases to ensure satisfactory completion and schedule alignment.  Determine if the test case prerequisites (e.g., test data and user account credentials provisioned) for validation testing are fulfilled.  Determine the scope of retesting required following defect fixes or risk identified.  Ensures that product deployments/implementation projects are validated per appropriate Validation Plans.  Review lifecycle deliverables agreed upon for the project to ensure they are authored, approved, and executed to meet quality standards.  Review lifecycle documentation related to products; consider current standards and regulations to ensure that outputs have been completed before becoming a final product.  Maintain the validation deliverable package in an audit-ready state  Supports revision of applicable procedures, policies, and work instructions to ensure compliance with local and international regulations.  Provide supervision and coaching to team members as needed.  Liaise with functional representatives and product management, product owner, validation, and testing staff to problem-solve directly or escalate issues.  Ensure that development and business processes comply with internal standards, regulatory requirements, and industry best practices by participating in and facilitating process validations.  Conduct quality assessments and validation of third parties  Participate in audits and inspections as required, providing applicable validation documents and process overviews Education  Technical Education (Bachelor's degree or equivalent) in computer sciences, health/life sciences, or equivalent is required, as is relevant work experience in a product development environment. Experience  Preferred at minimum 2 years of experience with Design Controls (e.g., Computer System Validation) and Quality Management systems (21 CFR Part 820, ISO 9001, ISO 13485) in a regulated environment.  Preferred at least 1 years working in cGMP and/or GCP-regulated environments.  Experience with risk-based validation  Knowledge of and ability to apply GAMP5 and CSA guidelines  Good troubleshooting and communication skills  Experience In Audits And Inspections Is Preferred  Good command of English. Additional language skills are preferred.  Experience participating in the CAPA resolution process.  Excellent skills in analyzing issues and processes.  Team-oriented with excellent communication and organizational skills.  Strong interpersonal and communication skills, both verbal and written  Goal oriented  Detail oriented  Ability to make sound judgments  Superior problem-solving skills  Ability to manage multiple tasks effectively & efficiently Work Environment Remote Travel less than 20% to an office environment Physical Demands This position requires frequent and repetitive use of a computer, keyboard, and mouse, as well as hand and finger dexterity. Other Duties Contributes to team effort by  Exploring new opportunities to add value to organization and departmental processes.  Leveraging technical knowledge to troubleshoot issues  Communicating risks, defects, and quality issues to ensure process transparency  Identifying potential risks related to quality/testing and developing mitigations  Maintain the status of documents in design projects.  Establishing knowledge of all core lifecycle processes  Contributes to the establishment and tracking of KPIs and Metrics for the department Maintains Professional and Technical Knowledge by  Attending and participating in applicable company-sponsored training  Attending educational workshops and reviewing professional publications  Benchmarking state-of-the-art practices  Participating in professional societies  Keeping informed of changes in the regulatory environment and/or regulatory requirements  Please note that this job description is not designed to cover or contain a comprehensive listing of the activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice. EEO  Saama Technologies, LLC. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Description Saama - Technical Project Manager - JD Reports to: Program Manager Job Description ❖ Required / Must Have Skills Strong project management skills, including planning, execution, and risk management. Excellent communication and interpersonal skills, with the ability to effectively communicate with technical and non-technical audiences. Proven ability to lead and motivate cross-functional teams. Technical background or understanding of the technologies involved in the project. Minimum of 10 years of hands-on experience in Application programming. Ability to adapt to changing priorities and manage multiple projects simultaneously. Strong analytical, problem solving, troubleshooting & debugging skills. Knowledge on Python (otherwise Java or DotNet), SQL, Data Engineering, Data Analytics tools, AWS, etc. ❖ Good to have skills Good understanding of one or more of the following Clinical Systems ■ EDC Systems such as Medidata Rave, Veeva EDC, Oracle Clinical, Medrio, InForm, etc., ■ CTMS Systems such as Siebel CTMS, Medidata CTMS,Veeva CTMS, etc., ■ IRT Systems such as YPRIME, Parexel Clinphone, etc., ■ LAB Systems such as central Lab, local Labs etc., Good understanding of clinical trial domain & overall EDC study setup & reporting process.

Description 15+ years of experience in the field of clinical domain and must have at least 5+ years of experience in the field of SAS programing in generating SDTM, ADM, TLF and complete submission package preparation. Must have a solid understanding of end to end clinical domain from Drug discovery to Regulatory approval process. Must have worked as an Business Analyst or Product Manager on Clinical Systems development. Having experience in Statistical Computing environments will be of great advantage. Proficiency in solution design within the clinical business, conduct demos to internal and external stakeholders. Very good in collaboration with Customers and internal technical stake holders. Ability to ideate and write requirement specifications and thorough hands on with the latest SDLC process and tools used in the application development. Ability to manage and guide the BAs, Testers and developers in all the functional aspects and provide Test data support. Ability to perform user acceptance testing as per the business use cases and report the issues. An excellent team player and people management skills to manage the teams as needed. Must be flexible working in the global work environments. Must be abreast of latest news and innovations in the Clinical / Life Sciences industry Understanding of application of Gen AI on clinical use cases, problem solving ability using Gen AI will be of great advantage

Description Analyzing and translating business needs into long-term solution data models. Evaluating existing data systems. Working with the development team to create conceptual data models and data flows. Developing best practices for data coding to ensure consistency within the system. Reviewing modifications of existing systems for cross-compatibility. Implementing data strategies and developing physical data models. Updating and optimizing local and metadata models. Evaluating implemented data systems for variances, discrepancies, and efficiency. Maintain logical and physical data models along with accurate metadata. Analyze data-related system integration challenges and propose appropriate solutions with strategic approach Should have Strong knowledge in Databases, cloud technologies, Data Valut Architecture.

Description Associate QA Engineer Job Summary An Associate QA Engineer, a role focused on ensuring product quality, develops and executes test plans, identifies defects, and collaborates with development teams to improve product quality, often working under the guidance of senior engineers. Knowledge, Skills & Abilities Knowledge of programming languages like python , Java. Knowledge of SQL, performance tuning and experience with Bigquery/Snowflake. Knowledge of Datamodels, GIT, Jenkins. Experience with Cloud platforms like GCP,ACW, Azure. Strong analytical and problem-solving skills with the ability to synthesize information, summarize issues and think creatively. Excellent communication skills and able to convey information clearly and concisely . Education And Work Experience Graduation or any equivalent qualification from a reputed institution. 0-2 years of experience Overall aggregate of the Candidate should be above 60% with no history of Arrears. Job Description Develop ETL Pipelines/Applications (Coding and Programming using SQL, Python, AWS, Snowflake, GCP, Azure) Testing and Debugging ETL code Documenting and Testing new Software Applications Researching, Investigating and fixing wide range of technical issues Collaborating with Senior leaders Proactively learning about new Technologies Problem solving in different data domain and creating solutions About US Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product based industry services and accelerators. Discover more at saama.com. Benefits Relocation Support: Assistance provided to employees who need to relocate for work. Learning & Certifications: A dedicated budget to support continuous learning and professional growth for all full-time employees. Self-Learning: Employees can avail ₹5,000 per quarter for self-learning courses, with a maximum of 3 sessions per quarter. Professional Certifications: A reimbursement of up to $700 per year for professional certifications, with a limit of 2 certifications annually. Leave Policy: Employees are entitled to 15 earned leaves per year, along with an additional 12 leaves (sick leave or casual leave) for better work-life balance. Tax-Saving Options: Various benefits are available to help employees optimize tax savings, including: Meal vouchers for daily expenses. Contribution to the National Pension Scheme (NPS) for retirement savings. Voluntary Provident Fund (VPF) to enhance long-term financial security. Group Mediclaim Policy: Comprehensive health coverage for employees and their families. Employee, Spouse, and Children: Covered up to ₹5 lakhs. Parents & In-Laws: Covered up to ₹3 lakhs. Lean IN Initiative: A women-centric program designed to empower and support female employees in their leadership and professional development journey.