Actalent REMOTE Statistical Programmer in Waltham, Massachusetts
The Role: The Statistical Programmer will provide expert-level hands-on principal programming support and technical leadership to develop, maintain, validate, and run SAS computer programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. The Principal Statistical Programmer performs the statistical programming required for analysis of clinical trial data on projects of moderate to high complexity for in-house and out-sourced clinical trials, clinical pharmacology analysis, modeling analysis and any other ad-hoc analyses as required.
· Acts as lead and takes ownership of multiple studies within a drug program whilst providing support across various drug platforms.
· Acts as an integral member of project team. Attends project team meetings, works with vendors, clinical pharm, regulatory, and clinical team members as appropriate
· Leads Submission Working Group programming activities related to clinpharm deliverables
· Serve as a lead programmer in the production of all tables, listings, and figures, and Case Report Form (CRF) tabulations for clinical trial programs including ISS/ISE
· Serve as a lead programmer to support clinical pharmacology requests, ad hoc analyses, biomarker analyses etc.
· Evaluates and/or identify opportunities for standardization across projects.
· Communicates strategically with CROs regarding data and other clinpharm deliverables..
· Codes SAS utility macros; writes and implements test plans to support SAS macro development
· Programs statistical analyses (i.e., tables, listings, figures,) using SASÒ supporting clinical pharmacology, regulatory requests, ad-hoc analysis, integrated modeling analysis.
· Follows good programming practices and adequately documents programs
· Understands and follows FDA regulations which affect the reporting of clinical trial data
· Participates in cross functional task forces and initiatives representing Statistical Programming
Desired Experience/Education and Personal Attributes:
· B.A. / B.S. with at least five years of relevant experience or an M.S. with three years of experience
· Good analytical skills
· Ability to communicate technical concepts clearly and concisely to non-technical colleagues
· Strong organizational skills, attention to detail, and the ability to learn technical and clinical aspects of a clinical trial
· Successfully completed several large or complex projects
· Detail oriented
· Ability to handle multiple projects with aggressive timelines
· Leader and team player
· Working knowledge of clinical pharmacology datasets.
· Ability to multitask and prioritize work
· Excellent knowledge of SAS
· Familiarity with coding dictionaries (WHO, MedDRA)
· Knowledge of pharmaceutical standard initiatives such as CDISC
· Knowledge of medical and statistical terminology
· Capable of using Windows, Word, Excel
· The ability to work independently and expert SAS programming experience is required
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.