Location: Boston, MA
Description: The Biostatistician II collaborates with senior statisticians and biomedical researchers on research projects, with the current focus on clinical trials in HIV treatments, in particular, the treatment of children infected with HIV and other pathogens. This involves evaluating new medications and determining their optimal dosage across the pediatric age and weight spectrum, as well as preparing materials for regulatory submissions in support of our pharmaceutical partners with drug license applications.
In addition, the statistician may contribute to other research areas; for example, our work with TB aims to elucidate host and bacterial factors resulting in protection against TB infection, to examine novel biomarkers, and to evaluate new diagnostics using samples from biorepositories coupled with existing clinical data.
Major duties and responsibilities:
- Serve as study statistician, collaborate directly with the clinical trial team, with minimal supervision from senior statistician in the design, implementation, monitoring, analysis, and publication of research studies, including clinical trials and observational studies. Specific duties include:
- Develop and/or review the proposed study methodology, outcome measures, and related study features of proposals and protocols, to ensure conformance with accepted statistical principles; recommend revisions and modifications as needed
- Develop and write statistical considerations for protocol documents and create statistical analysis plans according to study design and appropriate statistical methods
- Develop and/or review study progress, data, and safety monitoring plans, outcomes review plans
- Collaborate on the development and/or review of other study documents needed to ensure the integrity of study
- Collaborate on the development and/or review of data collection forms, screening and randomization materials, and data management methods to ensure that the data to be collected will meet study objectives and allow valid analyses
- Ensure the integrity of data collection, review, compilation and analysis by monitoring protocols and procedures
- Identify potential or actual administrative or scientific problems; suggest and implement corrective action
- Prepare periodic and ad hoc data status reports
- Conduct ongoing, periodic and final analyses of data, using specialized statistical techniques and statistical programming. Determine proper summary statistics, report formats and address all other analysis considerations
- Collaborate with clinicians, senior statisticians and other protocol team members on manuscripts, abstracts, presentations and publications documenting study findings
- Participate in peer review and critique of reports and analyses from studies conducted by colleagues
- Take leadership roles in activities at Frontier Science related to statistical analyses, programming, and procedures, such as:
- Write guidance documents for regulatory submissions
- Draft operating procedures and work instructions
- Create SAS macros to facilitate data preparation or data analysis tasks that are performed often
- Collaborate in the resolution of technical problems
- Participate in regulatory submission work for clinical studies, with responsibility for analysis implementation plans (AIPs), output mock-up (MOCKs), programs to create ADaM datasets and TFLs, along with relevant documentations (ADRG, P21, define.xml etc. when appropriate)
- Maintain professional knowledge and expertise
- Participate and help with implementation of Frontier Science Boston statistical computing capacities. An example might include proposing and developing SAS macros to make the work more efficient
Reports to: The Biostatistician II Reports to supervisor and/or senior statisticians involved with assigned projects, with assignments coming from supervisor and/or Director of Biostatistics.
- Master's Degree in Biostatistics, Statistics, or a closely related field
- At least 2 years of statistical experience with multi-center clinical trials, or equivalent collaborative statistical experience
- Ability to independently analyze data from clinical trials and observational studies using standard statistical techniques
- Strong programming skills in SAS are very desirable; but skills in other statistical computing languages such as R will be considered
- Excellent oral and written communication skills, with the ability to effectively collaborate with protocol teams, which include but are not limited to study chairs, medical officers, protocol specialists and data managers
- Strong preference for individuals with experience in Phase I/II dose-finding studies, FDA regulatory submissions, and constructing/handling CDISC datasets
- Experience with MS Office (Word, Excel, PowerPoint)
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.