Biostatistician/Statistical Project Manager For Regulatory Submission Studies

Job Summary

Position Description

• Assignment of work (protocols, ancillary studies, data and specimen requests, validation, etc.) to MS-level Biostatisticians and Statistical Programmers.
• Ensuring reasonable timelines and prioritization for completing work and equitable distribution of assignments.
• Identifying areas for training and improving work efficiency.

• Developing project plans for regulatory submission studies
• Reviewing drafts of planning documents (e.g., Statistical Analysis Plan and Analysis Implementation Plan) from a regulatory submission perspective
• Providing guidance and training on regulatory submission activities, processes, and deliverable
• Audit/inspection readiness

• Development of efficient and compliant processes, practices, standards, documents, templates, guidance, and training for regulatory submission studies within the organization
• Preparation and review of project management reports on work progress and completion
• Leading and preparing agendas for submission study statistician/programmer meetings and regulatory working group meetings
• Communications with pharmaceutical company partners, including tracking requests and decisions
• Audit/inspection preparations, conduct, and responses
• Supervise CBAR MS-level Biostatistician IIs or Statistical Programmers who work on studies with major regulatory components, as needed
• Other duties as assigned

• 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 principle
• 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

Basic Qualifications

• Master's Degree in Biostatistics, Statistics, Epidemiology, or a closely related field required
• 5+ years of related statistical experience, including with multi-center clinical trials involving regulatory submissions required; a combination of experience and education may be considered
• Experience with statistical software (such as SAS, Stata, etc.) required

Additional Qualifications and Skills

• Two-year MA/MS program
• Prior supervisory experience
• Statistical experience with multi-center clinical trials, including Phase I or Phase I/II trials, or equivalent collaborative statistical experience
• Statistical experience with clinical trials supporting regulatory approval (e.g., FDA or EMA)
• Highly specialized and technical knowledge of statistical analysis techniques and principles including categorical data and censored failure time data analysis
• Advanced computer skills and experience with major statistical computing packages
• Experience in effectively collaborating with study chairs, medical officers, protocol specialists and database managers
• Experience with independently analyzing data from clinical trials using standard statistical techniques
• Experience contributing to the writing of manuscripts, abstracts, and other publications documenting study findings
• Experience with SAS, or strong background in other relevant packages (e.g., STATA, S-PLUS or R)
• Experience with MS Office (Word, Excel, PowerPoint)
• Familiarity with medical terminology
• Strong written and verbal communication skill

• Awareness of and aptitude to appropriately and effectively understand, respect, and adapt to cultural and identity-based difference within group environments
• Knowledge of and commitment to concepts and issues tied to social justice, diversity, equity, and inclusion
• Skills related to creating and supporting an environment that allows for inclusion, effective intercultural engagement, and personal humility and authenticity

Additional Information

• The Harvard T.H. Chan School of Public Health does not provide visa sponsorship, now or in the future, for staff positions.
• Harvard University requires pre-employment reference checks and background screenings.
• This position has a 120 day orientation and review period.

Benefits

• Paid Time Off: 3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers.
• Health and Welfare: Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date.
• Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more.
• Retirement: University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service.
• Tuition Assistance Program: Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools.
• Tuition Reimbursement: Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions.
• Professional Development: Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning.
• Commuting and Transportation: Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more.
• Harvard Facilities Access, Discounts and Perks: Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston.

Work Format