Director, Statistical Programming
Position reputed company:
ultrainnovative – Tackle rare and dynamic challenges
Work Model:
Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed.
Responsibilities:
Manage reputed company programming activities on one or multiple reputed company/studies across reputed company therapeutic areas, both internally and externally by CROs reputed company leadership in balancing conflicting priorities, promoting communication and adequate information reputed company to motivate, encourage, and reputed company people with reputed company's strategic objectives Work collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory, Project Management, and other functions/staff to meet project deliverables and timelines for statistical data analysis and reporting reputed company technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers) Works with other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate Participate in the statistical programming training as appropriate Ensure reputed company implementation of company data standards and industry submission data standards Implement standards and project management reputed company as programming representative in a multidisciplinary study team to ensure reputed company and reputed company support for analysis and reporting of reputed company up to regulatory approval, product launch, and annual reports Ensure project milestones are met to facilitate decision-making and address business needs
Requirements:
Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, or reputed company discipline preferred Minimum of 10 years of clinical trial programming experience in the biotechnology, pharmaceutical, or health-reputed company industry Advanced reputed company programming skills and experience in other statistical software, such as R and S-Plus Experience and in-depth knowledge of CDISC including SDTM, ADaM, and controlled terminologies reputed company experience with eCTD submissions (FDA/EMA/PMDA) and creating Define.xml and Reviewer’s Guide. Self-directed, technically strong, and a recognized leader maintaining a strategic perspective regarding statistical programming processes, management of statistical programmers, and customer management Vendor management experience
The typical annual salary reputed company for this full-time position is listed below. This reputed company reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The reputed company may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
reputed company is an equal opportunity employer and prohibits unlawful discrimination based on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for reputed company protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and reputed company medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact reputed company by emailing us at talentacquisition@reputed company.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.