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Setting the new standard for biometrics to advance the clinical trial process.
Programmer II
Location
India
Posted
62 days ago
Salary
0
Seniority
Mid Level
Job Description
Programmer II
Veramed
Role Description The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients, and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management). Key Responsibilities - Technical: - Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs - Author, review and approve study TFL shells and dataset specifications - Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice - Identify data issues and outliers - Complete, review and approve CDISC Validation tool reports - Identify data and standards issues and resolve or escalate as appropriate - Awareness of emerging standards and associated impact to ongoing and future planned trials - Maintain proficiency in SAS and awareness of developments - Maintain study master file documents and any other documents that are required to be audit ready - People Management: - Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports - Provide coaching and mentoring of staff to achieve “excellence”. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs - Interview and effectively on-board and integrate new staff members - Provide programming technical leadership and coaching - Project Management: - Oversight of key client projects/portfolios. To include: - Being Veramed Project Manager on client accounts and projects - Maintain the project plan - Proactive management of resource, scope change and risks - Manage the delivery of projects to budget - Manage client expectations and issue resolution - General: - Lead internal and client study, project and cross functional team meetings effectively - Present study updates internally and at client meetings - Share scientific, technical and practical knowledge within the team and with colleagues - Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training - Build effective collaborative working relationships with internal and client team members - Ensure learnings are shared across projects or studies - Develop and provide internal technical training where appropriate - Lead process improvement initiatives Qualifications - BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience) - At least 8 years of relevant industry experience Requirements - Understanding of clinical drug development process, relevant disease areas, endpoints and study designs - Awareness of industry and project standards & ICH guidelines - Excellent verbal and written communication skills - Interpersonal/teamwork skills for effective interactions - Proficiency in data handling using SAS or other statistical software (e.g. R) - Self-management skills with a focus on results for timely and accurate completion of competing deliverables - Demonstrated problem solving ability and attention to detail - Ability to work independently and as part of a team - Ability to manage a portfolio of projects and/or people Benefits - Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability. - As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. - We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. - All qualified applicants will receive equal consideration for employment.
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