The Senior Statistical Programmer will work directly with the stakeholders to lead and contribute to statistical programming projects and to ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements. The Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets and will ensure audit readiness for all tasks. They will provide mentoring and training to statistical programming staff members and may lead or contribute to the design of new statistical programming processes or optimization of existing ones.JOB RESPONSIBILITIES: :Lead statistical programming activities for assigned projects, which will include projects expected to be submitted to regulatory authorities and may include pooling projects (ISS/ISE). :Co:ordinate activities of all programmers assigned to the project, ensuring high quality, respecting project timelines and adherence to the budget. :Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of project requirements, scope of work and timelines.:Provide relevant training and mentorship to staff and project teams on SAS techniques and clinical trial data with respect to CDISC standards and other regulatory requirements.:Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. :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.:Understand and follow all relevant standard operating procedures (SOPs).:Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. :Maintain up:to:date knowledge of programming software (e.g. SAS, R, Python) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.:Occasionally, lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.QUALIFICATIONS: Education: BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics). Master's Degree preferred.Experience: :6 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.:Experience as a lead statistical programmer working with global cross functional teams is required.Skills: :Fluent in English,:Proficient in SAS,:Project management, organizational skills, ability to manage competing priorities, and flexibility to change.:Good understanding of drug development process, including knowledge of interfaces and interdependencies with other functions.:Good time management and interpersonal skills,:Written/verbal communication and presentation skills are needed along with the ability to establish and maintain effective working relationships with coworkers, managers and clients.LI:PJ1

Senior statistical programmer

, IN

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.Working under the direction of the Principal Programmer,thesenior statistical programmerconducts programming activities for a trial, early phase project, indication, or publication activities. Lead at least one study team in terms of providing technical and domain:related guidance. May require to lead and manage a team of 2:4 members Ability to work on data migration from legacy datasets to standards such asCDISCor any other client:specific standard. Read and understand the program specifications document. Prepare SAS analysis datasets, tables, listings, and figures as per specifications. Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on:time quality delivery. Validate and transform datasets as per client assignment specifications. Validate tables, listings, and figures as per client assignment specifications. Coordinate with the client and US team for clarity of specifications, data issues, outliers, reviews, schedules, etc. Contribute to the organization's recruitment process by identifying needs and required skill set of resources and conducting interviews to hire appropriate resources. Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicableQualifications and Experience: Bachelorsor Masterssdegree in Computer Science, Statistics, or related health science field with 5 plus years of SAS programming experience with clinical trial data. CDISC experience is required. Well conversant with regulatory requirements and drug development process. Good understanding of the Clinical trial domain and good SAS programming skills Ability to work independently.Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.