Biostatistician/Statistical PM

  • Anywhere

Company :
Harvard College

Location :
Cambridge, Massachusetts

Expiry Date :
Sun, 08 Nov 2020 23:59:59 GMT

Apply Job :
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Description :
* Master’s Degree in Biostatistics, Statistics, or a closely related
field required
* 5+ years of related statistical experience, including with
multi-center clinical trials or equivalent collaborative
statistical experience, required; a combination of experience and
education may be considered
* Experience with statistical software (such as SAS, Stata, etc.)
Please attach the following when applying: 1) Resume, 2) Cover letter,
3) Transcript (official or unofficial) from MA/MS program and 4) Names
and email addresses for three (3) professional references.
* Two-year MA/MS program preferred
* Prior supervisory experience preferred
* Professional experience and/or education in statistical analysis
or clinical or biological data, including failure time and
categorical data, preferred
* Specialized and highly technical knowledge of statistical design,
monitoring, analysis, and reporting techniques in clinical
research studies preferred
* Understanding of statistical principles associated with clinical
trials, categorical data, survival data, longitudinal data, and
diagnostics studies preferred
* Advanced computer skills and experience with major statistical
computing packages preferred
* Experience independently designing, conducting, monitoring, and
analyzing data from clinical trials preferred
* Experience independently preparing written reports and manuscripts
for publication and summarizing study results preferred
* Experience meeting deadlines and directing other staff, and
experience with managing successful projects preferred
* Experience with MS Office (Word, Excel, PowerPoint) preferred
* Advanced SAS and R software skills preferred
* Excellent oral and written communication skills with experience
effectively collaborating with senior medical investigators and
data managers preferred
* Knowledge of medical terminology and medical research methods
Duties and Responsibilities continued:
The remainder of this position s time will be spent acting as a senior
biostatistician, collaborating directly with medical researchers in
the design, implementation, analysis and publication of IMPAACT Phase
I through Phase IV clinical trials and observational studies. This
position will also serve on internal committees.
Senior biostatistician responsibilities include, but are not limited
to, the following:
* Conduct ongoing, periodic and final analyses of data, using
specialized statistical techniques and programming
* Review proposed protocol and study methodology, to ensure
conformance with accepted statistical principles
* Write statistical considerations for protocol documents and study
proposals, according to appropriate statistical methods
* Oversee development of data collection and data management methods
to meet study objectives and allow valid analyses
* Develop randomization and stratification materials in compliance
with protocol design
* Ensure the integrity of data collection, review, compilation and
analyses by monitoring protocols, databases, and procedures
* Identify potential or actual administrative or scientific
problems; suggest and implement corrective action
* Collaborate with clinicians on manuscripts, abstracts and other
publications documenting study findings
* Maintain professional knowledge and expertise as well as an
awareness of emerging scientific areas
* Assist Senior Researchers with supervision and direction of less
experienced master s or bachelor s level biostatisticians; serve
as the primary supervisor as needed
* Take leadership roles in activities within CBAR and in a
Project/Network, such as heading a CBAR committee or providing
technical support to a Network-level committee or working group
* Other duties as assigned
* Harvard University requires pre-employment reference checks and
background screenings.
* This position has a 120 day orientation and review period.
* The Harvard T.H. Chan School of Public Health does not provide
visa sponsorship for administrative and staff positions.
The Harvard T.H. Chan of Public Health is dedicated to building a
diverse community of individuals who are committed to contributing to
an inclusive environment including fostering respect for all,
serving the greater good, and welcoming individuals from diverse
backgrounds, experiences, and perspectives. To learn more about the
Chan School s mission, objectives, and core values, please visit our
website here.
Harvard offers an outstanding benefits package including:
* Time Off: 3- 4 weeks paid vacation, paid holiday break, 12 paid
sick days, 11.5 paid holidays, and 3 paid personal days per year.
* Medical/Dental/Vision: We offer a variety of excellent medical
plans, dental & vision plans, all coverage begins as of your start
* Retirement: University-funded retirement plan with full vesting
after 3 years of service.
* Tuition Assistance Program: Competitive tuition assistance
program, $40 per class at the Harvard Extension School and
discounted options through participating Harvard grad schools.
* Transportation: Harvard offers a 50% discounted MBTA pass as well
as additional options to assist employees in their daily commute.
* Wellness Options: Harvard offers programs and classes at little or
no cost, including stress management, massages, nutrition,
meditation and complimentary health services.
Harvard access to athletic facilities, libraries, campus events
and many discounts throughout metro Boston.
Join the Harvard T.H. Chan School of Public Health to support our
mission of health research and education, and to be a part of the
oldest institution of higher learning in the country!Job-specific
responsibilities include, but are not limited to, the following:
Up to fifty percent (50%) of this position is dedicated to statistical
project management for regulatory submission studies for the IMPAACT
Network, which involves close collaboration with the Regulatory
Submission Unit (RSU) at CBAR s collaborator/subcontractor, Frontier
Science. The project management aspects of the role include, but are
not limited to, the following:
* Working with project leadership and RSU leadership on:
* Assignment of scientific work for regulatory submission
studies (protocols, ancillary studies, data and specimen
requests, validation, etc.) to MS-level Biostatisticians and
Statistical Programmers
* Ensuring reasonable timelines for completing work and
equitable distribution of assignments
* Working with the RSU and the CBAR Quality Team on:
* Development of efficient and compliant process and practices
within the organization to ensure that work is done in
accordance with standard operating procedures and best
* Identifying areas for training and improving work efficiency
* Audit/inspection readiness
* Assisting project leadership with:
* Preparation and review of project management reports on work
progress and completion, including annual progress reports
* Audit/inspection preparations, conduct, and responses
* Supervising CBAR MS-level Biostatistician I and IIs,
Statistical Analyst/Programmers, or Statistical Programmers
who work on studies with major regulatory components, as
* Other duties as assigned
Duties and responsibilities will be continued in the "Additional
Information" section.
Please attach the following when applying: 1) Resume, 2) Cover letter,
3) Transcript (official or unofficial) from MA/MS program and 4) Names
and email addresses for three (3) professional references.
PLEASE NOTE: This position has a term end date of November 30, 2021,
with strong likelihood of renewal until 2027.
PLEASE NOTE: The primary work location for this position is Boston,
Massachusetts. Until our return to campus, which is still
to-be-determined, this interview process and position will be
conducted virtually including virtual interviews, remote onboarding,
and remote work. The remote nature of this position is only temporary.
Local, on-campus work will be required once the School and this role
return to an operational status that supports it, which is currently
anticipated to be by December 31, 2020.