• Contribute to company innovation projects (development and roll out).• Contribute to improve current processes following regulations.• Train, mentor and share knowledge with the rest of the statistical programming team.• Interact with customers on a project or program level.• Responsible for project management (timelines, scope, budget, resourcing) on a project or program level.• Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc).• Leading in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.• Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.• Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.• Development of SAS programs for study TFLs, based on study SAP and shells.• Review and verify all types of conversions and programming done based on customer requirements.• Development of core programs for validation, conversion and maintenance of clinical data dataset structure.• Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.• Ensure that all activities comply with Good Clinical Practices (GCP) standards.

• Uses SAS or other software 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, Biostatistician, and other project team members to resolve discrepancies or any findings.• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.• Keeps project team members informed of programming progress and issues requiring their attention.• May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.• Follows applicable SOPs, WIs, and relevant regulatory guidelines (.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, and verification/ quality control documents and programs.• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.• Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management.• Act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables.• Assists with the transfer of deliverables.• Performs other work-related duties as assigned

• Contribute to company innovation projects (development and roll out).• Contribute to improve current processes following regulations.• Train, mentor and share knowledge with the rest of the statistical programming team.• Interact with customers on a project or program level.• Responsible for project management (timelines, scope, budget, resourcing) on a project or program level.• Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc).• Leading in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.• Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.• Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.• Development of SAS programs for study TFLs, based on study SAP and shells.• Review and verify all types of conversions and programming done based on customer requirements.• Development of core programs for validation, conversion and maintenance of clinical data dataset structure.• Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.• Ensure that all activities comply with Good Clinical Practices (GCP) standards.

• Design and develop company standard SAS macros and other utilities to expedite SAS programming activities for biostatisticians

- Create SDTM datasets according CDISC-SDTM standards.- CRF annotations.- Writing new macros as per project requirements.- Create Tables and Listings as per SAP and Mock Shell provided. Ensure that all CRF fields are displayed on listings (as per requirement). Validation of Tables and listing prepared by developer.- Having experience of working on several high priority issues, monitoring end to end reports and preparation of daily and monthly reports using SAS.

Lead, or contribute to, statistical programming activities on BDM projects (development or QC of deliverables):• delivering exemplary performance and solving complex technical problems to inspire other programmers, • ensuring an efficient collaboration with BDM global teams (Europe, India, and US) • being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables, • being accountable for overall client satisfaction with these deliverables, • maintaining a detailed project and validation plan, • efficiently communicating with internal and external clients, • ensuring budget monitoring and adherence Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance: • Clinical study reporting, e.g. ICH E3 • Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11 • Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…) Understand, follow and ensure adherence to all BDM SOP as well as any other relevant SOPs. Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementationLast 1.5 year working in SDTM experts group as SDTM programmer with strong skills in CDISC.

Provide high-quality, timely & advanced programming support that conforms to current Quanticate and client-specific standard operating procedures and processes, as well as applicable regulatory requirements and guidelines on behalf of the client.

• Build SAS datasets from clinical database.• Develop SAS macros, templates and utilities for data cleaning and reporting.• Utilize SDTM guidelines to build datasets.• Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.• Write SAS programs to generate tables, listings, and figures and analysis datasets.• Validate the programmed analysis datasets, tables, listing and figures.• Review CRF annotations and data specifications.• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.