Location: Boston, MA
Description: The biostatistician collaborates with senior statisticians and medical researchers on clinical trials which may be national or international in scope. Our current focus is on treatments for HIV and other infectious diseases, but there is strong potential to expand into other areas of clinical research.
While participating in our current research projects, the statistician will have the opportunity to make contributions to the treatment of children infected with HIV and other pathogens. This involves evaluating new medications and determining their correct dosage across the pediatric age spectrum, as well as our regulatory submission work which supports 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 and to examine novel TB biomarkers using samples from biorepositories coupled with existing clinical data.
Major duties and responsibilities:
- Participate in regulatory submission work for clinical studies, with responsibility for analysis implementation plans (AIMs), output mock-up, programs to create ADaM datasets and TFLs, along with relevant documentations (ADRG, P21, define.xml etc. when appropriate)
- Serve as clinical trial protocol statistician
- Work closely with senior statisticians and clinical trial teams in the design, implementation, and monitoring of clinical trials, as well as the analysis and publication of results from clinical trials and observational studies
- Participate in peer review, along with critique of reports and analyses from studies conducted by colleagues
- Collaborate in the resolution of technical problems
- Maintain professional knowledge and expertise
- Perform the following specific duties under the direction of a senior statistician:
- 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
- Review the proposed study methodology, study parameters and related study features of proposals and protocols, to ensure conformance with accepted statistical principles. Recommend revisions and modifications as needed
- Develop stratification and randomization materials
- Oversee development of data collection forms and proposed data management methods to ensure that the data to be collected will meet study objectives and allow valid analyses
- Ensure integrity of data collection, data review, data compilation and analysis
- Prepare periodic and ad hoc data status reports
- Collaborate with clinicians, senior statisticians and other protocol team members on manuscripts, abstracts and other publication documenting study findings.
- Serve as statistician for the Frontier Science (FS) based projects
- Participate and help with implementation of Frontier Science Boston (FSB) statistical computing capacities. An example might include determining SAS macros that may be needed across projects that are conducted in the Frontier Science computing environment.
Reports to: The Biostatistician I reports to supervisor and/or senior statisticians involved with current projects, with assignments coming from supervisor and/or Director of Biostatistics. May become involved with non-pediatric projects in the future.
- Master's Degree in Biostatistics, Statistics, or a closely related field
- Experience working with data required for statistical analysis associated with clinical or biological research is desirable; however, recent graduates will be considered
- Strong programming skills in SAS are very desirable; but skills in other statistical computing languages will be considered
- Familiarity with CDISC data standardization, clinical trials database structure and management is a plus
- Experience in supporting clinical trials which involve regulatory submissions and in constructing/handling CDISC datasets is extremely desirable
- Excellent oral and written communication skills would be very helpful
- The potential to effectively collaborate with protocol team which include study chairs, medical officers, protocol specialists and database managers will be important
- Experience with MS Office (Word, Excel, PowerPoint) will be considered
Send resume/cover letter to email@example.com and include BIO1_091620 in the subject line.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.