Senior Manager – Biostatistics

Scholar Rock

. Provide statistical leadership for one or multiple clinical studies from Phase 1 through Phase 3 .

Posted 9/22/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $155,000 - $225,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in statistical leadership for clinical studies, with a strong foundation in statistical methodologies, clinical trial design, and regulatory compliance. Proficient in SAS and R programming, with the ability to manage multiple studies and influence cross-functional teams effectively.

Highest-signal resume keywords

Statistical LeadershipClinical Trial DesignSAS ProgrammingR ProgrammingFDA Regulations

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Statistical AnalysisStatistical ModelingStatistical Analysis PlansData InterpretationClinical Trial DesignRandomization SchedulesNDA/BLA/EMEA FilingsStatistical MethodologiesPharmacokinetic StudiesDose-Finding Studies

Soft Skills

Analytical ThinkingStrategic Problem-SolvingExcellent CommunicationSelf-MotivationOrganizational Skills

Tools & Technologies

SASR

Certifications & Qualifications

Doctorate Degree in StatisticsBiostatistics or Related Field

Industry Keywords

BiotechPharmaceuticalClinical DevelopmentRegulatory DocumentsClinical ProtocolsStudy ReportsInvestigator BrochuresStatistical DeliverablesCRO ManagementRare Disease Settings

About the role

Key responsibilities & impact

Provide statistical leadership for one or multiple clinical studies from Phase 1 through Phase 3
Provide statistical support for clinical trial design, including healthy volunteer trials, dose-finding studies, efficacy trials, safety trials, and clinical and pre-clinical pharmacokinetic studies
Conduct statistical analysis and modeling across development stages, including comparing study designs and implementing pre-specified or ad-hoc analyses
Develop or review Statistical Analysis Plans, mock TFL displays, and programming specifications for analysis datasets
Ensure high-quality statistical deliverables and lead data interpretation
Represent biostatistics in study team and clinical development team meetings and lead statistical discussions
Contribute to randomization schedules and supply management algorithms
Author statistical sections and contribute to regulatory documents, including clinical protocols, study reports, Investigator Brochures, INDs, briefing documents, and integrated summaries
Support regulatory interactions with agencies
Provide oversight of statistical activities outsourced to external vendors
Contribute to publications and scientific presentations
Participate in biostatistics activities throughout clinical development, from clinical design to regulatory submission
Perform day-to-day clinical statistician activities, clinical trial design, statistical analysis development, modeling, simulation, and analysis, and lead statistical deliverables

Requirements

What you’ll need

Doctorate degree in statistics, biostatistics or related field
A minimal of 2 years of relevant drug development experience in biotech or pharmaceutical companies for Senior Manager, or a minimum of 4 years for Associate Director
Ability to work independently, manage multiple programs/studies, remain highly organized and outcome-oriented, demonstrate self-motivation, and adapt in a fast-paced, growing environment
Strong analytical thinking and strategic problem-solving skills
Sound decision-making skills and the ability to navigate complex business and scientific challenges
Excellent communication skills in writing and in interactions with colleagues, including the ability to clearly describe advanced/complex statistical concepts and interpret results
Ability to influence cross-functional teams in a matrixed, global organization
Thorough and up-to-date working knowledge of statistical methodologies and clinical trial designs, with the ability to propose and implement novel approaches to accelerate clinical development and address challenges in rare disease settings
Thorough and up-to-date working knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
Experience NDA/BLA/EMEA filings experience is strongly preferred
Proficient in SAS programming
Proficient in R programming is strongly preferred
Experience managing CROs and external vendors is preferred
Ability to accommodate up to 20% travel or as business needs dictate