Member of cross-functional teams, the primary purpose of the position is to act independently and contribute to clinical studies or Medical Affairs studies, Exploratory/Regional work supporting complex/novel work within a development program (clinical/ observational studies, MA tactic, PK/PD and Biomarker analyses or regional project). This includes global accountability of all programmed deliverables at the study and submission level within assigned programs in one or more Primary Focus (PF) areas. In addition, the position is responsible for programming vendor oversight for assigned compounds and contributes to functional/departmental infrastructure projects.
The position acts independently as Global Programmer Lead (GPROGL) for an early stage or non-complex asset, supports the company's data transparency effort by programming statistical summaries for regulatory-mandated disclosure and represent Astellas on programming matters during inspections.
Under guidance, the position can also support the generation of complex TLFs, act as GPROGL late phase or offer training/mentoring to other programmers.
location: Telecommute
job type: Contract
salary: $70 - 80 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
For clinical trials, post marketing or early phase support and for asset support:
- Is responsible for the high-quality, on-time development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)),
- Is a key collaborator with statistics in ensuring that specifications are complete and statistical plans are executed efficiently with the right level of validation.
- Is the single point of contact for assigned studies, coordinates the activities of the programming team internally, and liaises with the lead programmer at the vendor (as applicable).
- Enforces the company, industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards) so that deliverables are ready to be used in regulatory submissions.
- Actively participates in the development and implementation of programming tools for Statistical Programming infrastructure projects.
- Leads Statistical programming activities related to the disclosure of company clinical trial data to regulatory agencies and research-based sites.
- Is responsible to efficiently communicate, at regular intervals, to Global Programmer Lead (GPROGL) and/or line management on study/project/initiative status and resource issues.
qualifications:
Required:
- Bachelor's or Master's in statistics, mathematics, or related field
- 6+ years with Masters OR 9+ years with Bachelor), of experience of relevant programming experience in the pharmaceutical industry and working with vendors
- 2+ years' experience as a lead programmer for a drug development program
skills: ADaM, CDISC, Statistical Programming
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
