Sr. Director, Biostatistics

Atavistik Bio; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

401(k) retirement plan

Medical, dental, and vision insurance

Flexible spending account

Job summary

Atavistik Bio, located in Cambridge, Massachusetts, is searching for a Sr. Director of Biostatistics to serve as the statistical lead for various clinical programs. You will provide technical leadership and statistical support, while collaborating across teams to ensure successful clinical study designs and regulatory submissions.

The ideal candidate holds a PhD in statistics with extensive experience in clinical trials, capable of communicating complex statistical concepts to a diverse audience. Atavistik offers competitive compensation, equity options, and a comprehensive benefits package.

Qualifications

• PhD in statistics strongly preferred; MS candidates must have relevant experience.
• Minimum 8 years of clinical trial experience.
• Experience in managing CROs and working with remote teams.

Responsibilities

• Lead statistical support for clinical studies and regulatory submissions.
• Oversee biostatistics and programming teams.
• Ensure high quality and timely reporting for clinical trials.

Skills

Statistical analysis

Leadership

Communication skills

SAS/R proficiency

Knowledge of ICH guidelines

Education

PhD in statistics

MS in statistics/biostatistics/mathematics

Tools

SAS

R

Job description

Company Summary

Atavistik Bio is a privately‑held clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Our proprietary AMPS™ platform allows us to rapidly unlock functional cryptic pockets across a broad range of target classes to accelerate the development of groundbreaking medicines. We have rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery.

Position Summary

We are seeking a Sr. Director of Biostatistics. Reporting to the Chief Medical Officer, you will act as the statistical lead for one or multiple programs, providing technical leadership and statistical support on the design, conduct and execution of clinical studies. You will oversee the statistics and programming team through an outsourced model and partner closely with cross‑functional teams, providing expert biostatistics input on development plans, regulatory interactions, and study design.

Key Responsibilities

• Key contributor on regulatory submissions and communication with global regulatory authorities
• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, and generate or review study randomization and sample size/power estimations
• Oversee and lead the vendor/CRO biostatistics and programming teams during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
• Execute or oversee individual projects, including meeting with project/study team members, conducting exploratory analyses, and providing analyses for publications
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners to achieve results for specific project needs
• Ensure the delivery of high quality and timely reports to project teams and the clinical trial team
• Develop and maintain statistical/programming policies, guidelines, and procedures (SOPs, training manuals, etc.)

Required Qualifications

• PhD in statistics strongly preferred; candidates with an MS in statistics, biostatistics, or mathematics and relevant experience in drug development statistical research will be considered
• A minimum of 8 years’ experience in progressive and relevant clinical trial experience
• Experience leading teams and working in a matrix organization
• Experience with blinded study designs and analysis of patient reported outcome (PRO) data sets strongly preferred
• Ability to communicate and work directly with non‑statisticians, imparting and delivering complex statistical information to scientific development partners and researchers
• Excellent communication skills with the ability to present to a variety of stakeholders and tailor messages accordingly
• Experience managing CROs and other data vendors
• Strong leadership with a growth mindset, willing to learn from others, and dedicated to promoting a collaborative work culture
• Ability to keep pace in a fast‑moving organization and navigate ambiguity
• Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian methods, missing data imputation, multiplicity adjustment
• Knowledge and proficiency in SAS or R and other industry computational tools
• Knowledge of CDISC standards including SDTM, ADaM
• Knowledge of ICH guidelines, FDA/EMA and other regulatory authority guidance
• Experience in planning, running and documenting simulations, including clinical trial simulations
• Experience working on site and with remote teams
• Ability and willingness to travel up to 10% as needed by the business

Benefits

Atavistik Bio offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for health care and/or dependent care.

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Equal Opportunity Employer

Atavistik Bio is an equal opportunity employer. All applicants will be considered for employment without regard to a person's race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any characteristic protected under applicable law.