Location: Boston, MA
The Biostatistician III acts as independent senior statistician, in collaboration with medical researchers, on US domestic and multi-national clinical trials. Our current focus is on studies of treatments for HIV and other infectious diseases, with potential to expand into other areas of clinical research. The Biostatistician III may have the opportunity to make major contributions to the treatment of children infected with HIV and other pathogens. The Biostatistician III may contribute to applications for funding, such as on grants and contracts obtained from the NIH. Examples of other potential clinical areas are: studies to elucidate host and bacterial factors resulting in protection against TB infection and disease, and to examine novel TB biomarkers using samples from biorepositories coupled with existing clinical data.
Major Duties and Responsibilities
- Act as protocol statistician, collaborating directly with medical researchers with minimal supervision from senior statisticians, in the design, implementation, monitoring, analysis and publication of national and international clinical trials and observational studies of treatments for HIV and other infectious diseases.
- 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 often done
- Lead ad hoc and/or ongoing committees tasked with solving problems that arise.
- The following specific duties are carried out independently, acting as senior statistician for specific studies:
- Review proposed study methodology, outcome measures and related features of proposals and protocols to ensure conformance with accepted statistical principles; recommend modifications.
- Determine and write statistical considerations for protocol documents and create statistical analysis plans, according to study design and appropriate statistical methods.
- Oversee development of data collection forms, screening and randomization materials, and data management methods to ensure that the data collected will meet study objectives.
- Ensure integrity of data collection, review, compilation and analysis by monitoring protocols and procedures to ensure data integrity and statistical validity.
- 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.
- Identify potential or actual administrative or scientific problems; suggest and implement corrective action.
- Develop screening and randomization documents.
- Prepare or oversee periodic and ad hoc data status reports.
- Collaborate with clinicians and other senior statisticians on manuscripts, abstracts and other publications documenting study findings.
- Participate in peer review/critique of reports and analyses.
- Maintain professional knowledge and expertise.
Reports to: Initially reports to lead statistician for Pediatric Studies; may become involved with non-pediatric studies at a later time.
May supervise junior statisticians and/or programmers, may coordinate resources for clinical trials or regulatory submissions.
- Master's degree or doctoral candidate in biostatistics, statistics or related field.
- At least 5 years of statistical experience with multi-center clinical trials, or equivalent collaborative statistical experience.
- Strong programming skills in SAS preferred; proficiency in another statistical computing language will be considered.
- Ability to independently analyze data from clinical trials and observational studies using standard statistical techniques.
- Excellent oral and written communication skills, with the ability to effectively collaborate with study chairs, medical officers, protocol specialists and database managers.
- Strong preference for individuals with experience in phase I/dose-finding studies, regulatory submissions, and/or supervising the creation and documentation of CDISC datasets.
Email resume/cover letter to firstname.lastname@example.org and include BioStat3_20190308 in the subject line.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.