Ephicacy

Roles and responsibilities: 1) Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required 6) Develop Debug Utility macros for reusability and efficiency Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Familiarity with multiple statistical procedures and functions to create TFLs Show more Show less

Experience Range: 8 – 14 years About the Role Primarily responsible for quality and timely delivery of CP reports (Data Validation Listings, Reconciliation Reports, Coding Review, CRF Metrics, Patient Profiles and Narratives). Thorough understanding of End-to-End Drug Development Process. Good data understanding and Analytical skills. Keen knowledge on Data Management and Data cleaning process and willingness to work for adhoc requests. Having a skill set of Database Knowledge and flow, Study Protocol, CRF Design, Coding Dictionaries, Central vs Local lab concepts. Experience in debugging system level macros and modifying them for study level. Develop utility macros for reusability and efficiency. Coordinate work on multiple projects according to priorities. Communicate with project team/stakeholders/other departments and/or groups effectively. Responsibilities Ability to program with and without specifications Reviewing and providing feedback on specifications when client provides them Ability to develop Macro from scratch or update existing macros Client Level Interaction not restricted to cascading work but setting up a project Ability to work independently and as part of a team Being open to new learnings and sharing with team members Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] Proficient in using SAS EG/Studio for programming Familiar with Unix environment and programming Experience with additional programming languages (R/Python, Spotfire) will be an added advantage. Qualifications Post-graduate degree in statistics, computing, life science related field B.E/B tech Required Skills Good data understanding and Analytical skills. Preferred Skills Experience with additional programming languages (R/Python, Spotfire) will be an added advantage Equal Opportunity Statement We are committed to diversity and inclusivity. Show more Show less

We are seeking a highly skilled Lead Statistical Programmer with expertise in SAS and R programming to support clinical trial data analysis and regulatory submissions. The ideal candidate will author and validate programs, manage client projects, and ensure compliance with CDISC standards and regulatory requirements. Key Responsibilities: Author, validate, and document SAS programs for datasets, TFLs, and macros, applying good programming practices. Develop and maintain programs in R , with hands-on experience in packages such as Tidyverse, Admiral, Create ADaM datasets using Admiral packages in R. Read and write raw data across SAS and R platforms. Conduct thorough debugging using R console tools. Review and approve clinical trial documents, dataset specifications , and TFL shells . Identify and resolve data issues, outliers, and standards-related discrepancies. Complete, review, and approve CDISC Validation Tool reports. Stay updated on emerging CDISC standards and assess impacts on ongoing and future trials. Maintain proficiency in SAS and awareness of developments in programming tools and standards. Ensure all study master file documents are audit-ready . Serve as Lead Programmer on client accounts and projects, managing client expectations and providing issue resolution. Provide input into and review of project management documents . Perform all work in full compliance with applicable legislation, regulations, company policies, and procedures . Actively contribute to internal and client study team meetings . Qualifications & Skills: Bachelor’s or Master’s degree in Statistics, Computer Science, Life Sciences , or a related field. Proven experience in SAS programming within clinical trials or pharmaceutical/CRO settings. Strong hands-on experience with R programming and relevant packages. Knowledge of CDISC standards (ADaM, SDTM) and regulatory submission requirements. Excellent problem-solving, debugging, and data validation skills. Strong communication skills to manage client interactions and cross-functional collaboration. Ability to work independently as well as lead project teams. Preferred Experience: Exposure to regulatory submissions and audit processes. Experience as a Lead Programmer managing timelines, deliverables, and client relationships.

Experience Range 11 – 15 years (minimum 5 years experience of R in SAS Programming) Skill : R Programming Expert with strong SAS expertise Technical Roles and Responsibilities 1) Lead end-to-end clinical reporting projects using R, ensuring timely and quality delivery. 2) Guide in Package development, Shiny app development at enterprise grade 3) Design and manage Shiny dashboards, internal tools, and reusable functions/packages. 4) Oversee SAS-to-R migration, translating legacy code with accurate validation. 5) Define and maintain standardized R programming frameworks. 6) Automate and optimize the existing process and applications 7) Ensure quality control, test coverage, and adherence to project specifications. 8) Guide Agile execution, client communications, and technical direction. 9) Support model lifecycle activities including deployment, version control, and monitoring. 10) Ensure regulatory compliance and proper documentation across deliverables. 11) Mentor, guide and drive team members for growth and development Customer & Delivery Management 12) Support & Supervise Programming team towards resolving study/program related issues 13) Communicate with project team/stakeholders/ other departments and/or groups effectively 14) Act as the customer key contact and responsible for project deliverables 15) Mentor and evaluate team members to establish training and coaching needs 16) Produce accurate project status and progress reports as necessary 17) Publish metrics as agreed with the client 18) Ensure 100 % compliance on customer trainings for all team members 19) Support and lead efforts to implement new concepts, process improvement, and technological advances for delivering outputs Skills Set: 1) Strong leadership, mentorship, and client communication abilities. 2) Effective in project management, task prioritization, and leading Agile teams (e.g., Jira, sprints, retrospectives). 3) Works collaboratively across functions including statisticians, data managers, and developers. 4) Ability to work independently and as part of a team 5) Being open to new learnings and sharing with team members 6) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 7) Proficient in using SAS EG/Studio for programming 8) Familiar with Unix environment and programming 9) Familiarity with multiple statistical procedures and functions to create TFLs 10) Ability to Lead and Mentor a team of junior programmers.

Experience : 10 to 15 years Title: Proposal Manager Location: Fully Remote - India Employment Type: Full-time About the Role: We are seeking a detail-oriented and proactive Proposal Manager to join our fast-growing global sales team within our proposal group. In this role, you will manage the end-to-end proposal process for our biometric service offerings, ensuring timely, high-quality, and competitive responses to RFIs, RFPs, and client requests. You will collaborate closely with Business Development, Operations, and Finance to develop compelling proposals, support budget development, and presentations that align with client needs and company capabilities. This position offers the opportunity to bring fresh ideas, contribute to new processes, and help shape the future of our proposal function. Success requires exceptional time management, communication, and organizational skills, with the ability to stay flexible and effective in a fast-paced, deadline-driven environment. Key Responsibilities • Manage and coordinate the full proposal lifecycle, including RFIs, RFPs, presentations and other client-requested deliverables. • Develop proposal strategies, timelines, and deliverables in collaboration with cross-functional teams. • Draft, review, and finalize proposal content (text and graphics) and supporting documentation. • Support the development of budgets (Excel tool) with subject matter experts. • Partner with business development, operations and finance to support contract development (NDA/CDA, MSA, SOWs, COs). • Create professional client-facing presentations to support business development and other sales/marketing activities, including bid defense meetings. • Ensure proposals are accurate, compliant, and submitted on time with highest quality. • Support the maintenance of proposal templates, library content (text and graphics), and implementing best practices to improve process efficiency. Qualifications • Bachelor’s degree in Life Sciences, Business, or related field (or equivalent experience). • Minimum of 8-10 years of aligned experience in proposals, business development, or contract management role within a CRO, pharma, or biotech environment. • Strong understanding of RFI/RFP processes, contract structures, and proposal development best practices. • Excellent written and verbal communication skills in English. • Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel); experience with Salesforce a plus. • Strong organizational skills and ability to manage multiple priorities in a fast-paced environment. • Detail-oriented with a focus on accuracy, compliance, and quality.

Experience Range 11 15 years (minimum 5 years experience of R in SAS Programming) Skill : R Programming Expert with strong SAS expertise Technical Roles and Responsibilities 1) Lead end-to-end clinical reporting projects using R, ensuring timely and quality delivery. 2) Guide in Package development, Shiny app development at enterprise grade 3) Design and manage Shiny dashboards, internal tools, and reusable functions/packages. 4) Oversee SAS-to-R migration, translating legacy code with accurate validation. 5) Define and maintain standardized R programming frameworks. 6) Automate and optimize the existing process and applications 7) Ensure quality control, test coverage, and adherence to project specifications. 8) Guide Agile execution, client communications, and technical direction. 9) Support model lifecycle activities including deployment, version control, and monitoring. 10) Ensure regulatory compliance and proper documentation across deliverables. 11) Mentor, guide and drive team members for growth and development Customer & Delivery Management 12) Support & Supervise Programming team towards resolving study/program related issues 13) Communicate with project team/stakeholders/ other departments and/or groups effectively 14) Act as the customer key contact and responsible for project deliverables 15) Mentor and evaluate team members to establish training and coaching needs 16) Produce accurate project status and progress reports as necessary 17) Publish metrics as agreed with the client 18) Ensure 100 % compliance on customer trainings for all team members 19) Support and lead efforts to implement new concepts, process improvement, and technological advances for delivering outputs Skills Set: 1) Strong leadership, mentorship, and client communication abilities. 2) Effective in project management, task prioritization, and leading Agile teams (e.g., Jira, sprints, retrospectives). 3) Works collaboratively across functions including statisticians, data managers, and developers. 4) Ability to work independently and as part of a team 5) Being open to new learnings and sharing with team members 6) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 7) Proficient in using SAS EG/Studio for programming 8) Familiar with Unix environment and programming 9) Familiarity with multiple statistical procedures and functions to create TFLs 10) Ability to Lead and Mentor a team of junior programmers.