Manager, Biostatistician

Site: The General Hospital Corporation

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

MGH is the largest research hospital in the United States with an annual research budget of over one billion dollars. The Neurological Clinical Research Institute (NCRI) at MGH was formed in 1994 to help foster clinical research in Neurology and conduct clinical research in neurological disorders. Under the direction of Drs. James Berry Sabrina Paganoni and Suma Babu the NCRI functions as a Clinical and Data Coordination Center for research studies and therapeutic trials in several neurological disorders such as the HEALEY ALS Platform Trial. NCRI also serves as the Coordination Center for the Northeast ALS consortium (NEALS) and the NINDS Funded NeuroNEXT network.
MGH NCRI is seeking qualified applicants with masters or doctoral degrees in Biostatistics or a related field to serve as the Manager Biostatistics for the HEALEY ALS Platform trial a high-profile major initiative at the intersection of academia and industry. This is a unique role for a biostatistician who enjoys combining hands-on work leadership and cross-disciplinary communication in a mission-driven setting. The position offers the chance to shape the design conduct and analysis of impactful research while mentoring a diverse team and collaborating with leaders across academia industry and regulatory bodies. The ideal candidate(s) will be comfortable leading the conduct and analysis of multisite randomized trials; effectively translating complex statistical concepts into actionable insights using their excellent oral and written communication skills; and contributing based on their balanced background in applied regulatory and methodological biostatistics. This is not a traditional academic role. While housed within a renowned academic institution the position offers the fast-paced solution-oriented environment of industry and is ideal for a candidate who thrives on impactful real-world applications.

Job Purpose
The Manager Biostatistics will be responsible for leading statistical operations including overseeing implementation of design analysis validation and reporting of data to support clinical research and investigational product development. The individual will ensure the application of rigorous reproducible statistical methods and error-free statistical programming (SAS R and/or other programming languages) to produce reliable and reproducible results. This individual will serve as a key biometrics advisor will work closely with Healey Trial leadership and will aid in the oversight of CROs contractors and interdisciplinary teams. The Manager Biostatistics will collaborate closely with the rest of the MGH NCRI external entities and regulatory bodies to address statistical and data-related challenges.

Responsibilities
Leadership and Project Oversight:
Serve as the statistical operational team lead for the HEALEY ALS Platform Trial overseeing the implementation of the design execution and reporting of each regimen.
Lead the development and review of statistical deliverables including protocols SAPs TLFs CSRs and regulatory submission documents.
Manage and oversee a team of junior level biostatisticians and statistical programmers.
Collaborate with cross-functional teams both within MGH NCRI and outside of MGH NCRI to ensure timely high-quality and budget-conscious delivery.
Foster effective communication organize and document meetings track progress and follow-up on actions.
Provide mentorship to junior team members and contribute to their professional development.
Statistical Analysis and Data Management:
Utilize advanced programming skills (using SAS R or other statistical programming languages) to generate accurate and reproducible results.
Collaborate on data management activities including database design validation checks data issue resolution and oversight of database lock and unblinding processes.
Manage statistical activities performed by CROs to ensure quality and timeliness.
Operational and Financial Accountability:
Develop project timelines forecast resource needs and identify and address potential out-of-scope work.
Collaborate with the contracts and finance team to monitor budgets control costs and track financial progress.
Support proposal development including input on RFPs budgets and participation in bid defenses as needed.
Risk Management and Quality Assurance:
Identify and proactively mitigate risks to project delivery and data quality.
Ensure adherence to regulatory requirements and internal standards in all statistical and data-related activities.
Contribute to the development of SOPs and internal policies to enhance operational efficiency.
Collaboration and Communications:
Act as a point of contact for MGH NCRI leadership trial biostatisticians and external stakeholders consulting on statistical and operational topics.
Partner with cross-functional teams to address challenges and drive project success.
Provide training on tools and applications developed by the biometrics group and contribute to knowledge sharing across the team.
Engage with internal and external collaborators to ensure alignment on project objectives and deliverables.

Qualifications
Applicants should meet the following qualifications:
PhD (or MS) in Biostatistics Statistics Computer Science Mathematics Engineering Life Science or related field.
5 years with a PhD or 7 years with MS focused on leading the conduct data coordination statistical analysis and reporting of multisite phase I-III randomized trials in the Pharmaceutical & Biotech industry.
Proficiency with SAS R or another statistical programming language.
Advanced knowledge of biostatistics and its application to different phases of drug development in a regulatory environment.
Expertise in a broad range of statistical methods including efficacy safety and PRO endpoints and experience with innovative study designs such as group-sequential platform and/or Bayesian adaptive designs. Experience in the neurology therapeutic area is preferred.
Knowledge of pharmaceutical clinical development (i.e. understanding of statistical concepts techniques and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus.
Proven ability to plan supervise and oversee statistical processes for multiple clinical trials.
Professional experience collaborating with non-statistical clinical investigators and coordinating with external vendors (e.g. central labs specialty labs CROs)
Demonstrated experience managing teams. Experience managing teams of data managers programmers and/or biostatisticians is desirable.
Exceptional attention to detail and organizational skills.
Strong ability to identify and resolve issues manage competing priorities and meet timelines consistently.
Self-motivated with a commitment to producing high quality on-time deliverables.
Excellent written and verbal communication skills with the ability to effectively collaborate with multidisciplinary teams.
Team-oriented mindset with the ability to foster collaboration and build productive working relationships.

Job Summary

Summary
Responsible for the overall direction and functioning of the biostatistics program and its processes to ensure alignment with agency strategic goals. Also responsible for supervision of the biostatistics program staff.

Does this position require Patient Care
No

Essential Functions
-Oversees and approves staff hiring work allocation training and performance management including required documentation as well as other supervisory functions.

-Monitor problem-solve and implement quality improvement initiatives that support program goals.

-Perform project management activities for identified projects including resource planning timelines and milestone management.

-Approve recommendations and solutions to resolve technical quality and timeline issues.

-Review and approve trial designs that address study objectives that will support regulatory approval and market access.

Education
Masters Degree Statistics required or Masters Degree Related Field of Study required

Can this role accept experience in lieu of a degree
No

Licenses and Credentials

Experience
Advanced Statistics/Biostatistics Experience 5-7 years required and Experience leading teams 2-3 years required

Knowledge Skills and Abilities
- Strong background in statistical programming using SAS or R.
- Knowledgeable with macros data sets computing statistics and writing protocols.
- Demonstrated proficiency with predictive modeling and can use critical thinking to assist with experimental design.
- Demonstrated time management skills and the ability to prioritize tasks as needed.
- Excellent communication skills both oral and written with the ability to explain technical data in laymans terms.
- Exceptional presentation and organizational skills.

WORKING CONDITIONS:

• Normal working conditions
• Hybrid work arrangement that combines the flexibility of remote work
• May be required to attend meetings outside of regularly scheduled hours
• Some travel may be required

Hybrid

399 Revolution Drive

40

Regular

Day (United States of America)

Pay Range

$97510.40 - $141804.00/Annual

Grade

8

At Mass General Brigham we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive and any offer extended will take into account your skills relevant experience if applicable education certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religious creed national origin sex age gender identity disability sexual orientation military service genetic information and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

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