Director/Senior Director, Biostatistics

rapportrx.com; Boston (MA); Hybrid; USD 235,000 - 305,000; Full time

Job summary

An established industry player is seeking a Director/Senior Director of Biostatistics to lead innovative statistical methodologies in clinical programs. This role involves overseeing the development of comprehensive statistical analysis plans, guiding cross-functional teams, and ensuring the integrity of statistical analyses. The ideal candidate will have extensive experience in biostatistics, a strong understanding of regulatory requirements, and a passion for improving patient outcomes. Join a dynamic team dedicated to pioneering precision neuromedicines and making a meaningful impact on patients' lives.

Benefits

Unlimited PTO

Lifestyle spending account

Commuting reimbursement

Flexible work schedule

Collaborative team environment

Qualifications

• 12-15 years of industry experience in biostatistics or related field.
• Experience with regulatory submissions and clinical trials.

Responsibilities

• Lead statistical analyses for clinical programs and trials.
• Develop statistical analysis plans and ensure regulatory compliance.

Skills

Statistical Analysis

Clinical Research

Regulatory Submissions

Project Management

Communication Skills

Statistical Methodologies

Education

MS or PhD in Biostatistics

Tools

SAS

R

Job description

Join to apply for the Director/Senior Director, Biostatistics role at Rapport Therapeutics

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors).

Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder.

The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are!

Your Impact

The Biostatistician will provide strategic leadership and ensure the integrity and scientific rigor of statistical analyses for clinical programs. Collaborating closely with cross-functional teams, this role will guide statistical methodologies, contribute to innovative trial designs, and help bring investigational therapies to successful regulatory approval.

Your Day-to-day

• Oversee the development of comprehensive Statistical Analysis plans for all clinical studies.
• Contribute to the design of all clinical protocols, including study designs, endpoint definitions, analysis strategies, and power calculations in collaboration with cross-functional development teams.
• Guide innovative statistical methodologies and trial designs, ensuring alignment with corporate and regulatory objectives.
• Oversee and manage outsourced statistical programming activities to ensure timely delivery of high-quality outputs, including tables, figures, and listings (TFLs).
• Review and approve statistical analysis plans (SAPs), and ensure appropriate methodologies are applied consistently.
• Interpret and present statistical results, translating complex data into clear, actionable insights for stakeholders.
• Ensure all statistical activities comply with relevant regulatory guidelines (FDA, EMA), ICH standards, and GCP principles.
• Support regulatory submissions and interact with regulatory authorities, data monitoring committees, and external advisors.
• Develop and implement best practices and standard operating procedures for biostatistics.

Must-Haves

• MS or PhD in Biostatistics, Statistics, or a related field with 12-15 years of industry experience (Director/Senior Director title commensurate based on experience)
• Experience working across multiple trials or programs within pharmaceutical or biotechnology settings, with a good understanding of disease areas and the drug development process
• Demonstrated ability to apply statistical skills to clinical research and development
• Knowledge of regulatory requirements for clinical studies, including ICH guidelines and FDA and EMA regulations
• Direct experience with regulatory submissions, including prior IND, BLA, or NDA filing experience.
• Expertise in neurological and psychiatric indications is highly desirable
• Proficiency in SAS and/or R software and experience working with complex data sets
• Familiarity with CDISC models (SDTM, ADaM)
• Strong knowledge of statistical methodologies, clinical trial design, and regulatory requirements.
• Excellent oral and written communication skills, with the ability to convey statistical concepts to non-statistical audiences.
• Proven ability to manage multiple projects and influence cross-functional stakeholders.
• A proactive and strategic thinker who can manage competing priorities and deliver high-quality results.

What Makes Rapport Special

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for this role to be $235,000-$255,000 for Director level and $280,000-$305,000 for Senior Director level. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.