Location: Boston, MA
The senior biostatistician acts independently and as the lead of a research team, to provide statistical direction in the design, implementation, conduct and analysis of clinical trial and/or observational study data. The senior biostatistician is responsible for the oversight of the work of other biostatisticians and programmers, and collaborates with a variety of people from academic, government and pharmaceutical industry partner organizations.
Major duties and responsibilities:
- Serve as a lead biostatistician for Frontier Science to create, test, document, and archive programs used for national and international clinical trials and observational studies of treatments for HIV and other infectious diseases analyses;
- Perform tasks related to statistical analyses, programming, and procedures, such as:
- Write guidance documents for submissions;
- Draft operating procedures and work instructions;
- Create SAS macros to facilitate data preparation and data analysis.
- Organize and maintain electronic documents, data, analysis programs, and reports;
- Determine and write statistical considerations for protocol documents;
- Write statistical analysis plans; determine proper summary statistics, report formats and address analysis considerations;
- Design study methodology, outcome measures and other portions of proposals and protocols to ensure conformance with accepted statistical principles and ICH guidelines;
- Provide direction for data collection form development and data management methods to ensure data will meet study objectives;
- Develop the methodology for screening and randomization documents;
- Ensure integrity of data collection, review, compilation and analysis by monitoring protocols and procedures; identify scientific problems; suggest and implement corrective action;
- Supervise and conduct ongoing, periodic and final analyses of data, using specialized statistical techniques and statistical programming;
- Prepare periodic and ad hoc data status reports;
- Present at professional meetings, design short courses to expand professional knowledge and expertise, and lead seminars and training sessions for FS biostatisticians;
- Work on a team to write proposals for new projects;
- Participate in writing and peer review/critique of analyses, reports, abstracts and manuscripts
- Supervise and train junior biostatisticians and/or programmers;
- Participate in other biostatistical work at FS, such as Independent Data Monitoring Committee (IDMC), or newly funded projects, as needed.
Controls over position: Work assigned based on project needs.
- PhD in Biostatistics/Statistics or equivalent;
- At least 3 years of experience as a Biostatistician, or similar position;
- Excellent command of SAS and/or R; strong working knowledge of MS Office Suite and excellent overall technical skills;
- Knowledge of clinical trials/research studies;
- Experience in phase I/II dose-finding studies, regulatory submissions, and/or supervising the creation and documentation of CDISC datasets;
- Leadership and self-direction;
- Ability to independently analyze data from clinical trials and observational studies using statistical techniques;
- Excellent oral and written communication skills;
- Strong attention to detail, excellent time management/organizational skills and ability to quickly pivot between tasks.
This position will be based out of the Boston, MA office but consideration will be made for a full time remote worker.
A cover letter must be submitted to be considered for this position.
Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.