The Head of Biometrics will be responsible for the strategic positioning and tactical advancement of Biostatistics and Data Management.
This role will be accountable for all Biostatistics technical plans and analyses, Data Management functions, Statistical Programming functions, and Clinical Systems.
Define and execute the strategic vision for the Biometrics Department.
Establish organizational structure for the Biometrics Department, including Statistical Programming, Data Management, and Clinical Systems functions. Lead and develop Biometrics employees.
Oversee and coordinate and be directly responsible for all biostatistics activities to support clinical development projects, delivering study designs and analysis plans, ensuring sound biostatistics principles and compliance with regulatory guidelines.
Advise on statistical issues associated with the design and analysis of clinical trials and provide biostatistics input on all major documents, including clinical development plans, protocols, data collection methodologies, statistical analysis plans, clinical study reports, and summaries of clinical safety and efficacy for regulatory filings.
Guide the application of epidemiologic methods to analyze observational/real-world data to calculate appropriate sample sizes, strengthen submission evidence and support drug development.
Provide review and guidance on statistical aspects, new programming, database technologies, clinical systems, and standards of all FDA/EMEA regulations and ICH & GCP guidelines.
Serve as the senior biostatistics representative supporting protocol/clinical document review, strategic and partner joint development activities, drug safety, and publication activities.
Collaborate with other senior development leaders to ensure consistency of development work standards, intellectually challenging assumptions, and sharing ideas.
Provide leadership for sponsor/CRO activities, relationships, and escalation resolution.
Interact as required with FDA/EMA and other health authorities to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development.
Support the development and implementation of best practices, SOPs, standards, work instructions, and policies for biostatistics.

Requirements

Ph.D. in Statistics or related fields and 15+ years of pharmaceutical industry experience, or Masters in Statistics and 20+ years of comparable experience.
Expert knowledge of ICH and other regulatory development guidelines.
Experience in recruiting, coaching, and developing talented team members.
Deep understanding of mathematical and statistical principles; demonstrated proficiency in at least one statistical analysis software (SAS preferably). Knowledge of other statistical software is a plus.
Experience in Phase 1-4 clinical development of a wide range of therapeutic areas, direct experience in pulmonary disease (i.e., idiopathic pulmonary fibrosis) is a plus.
Stellar communication and presentation skills. Must be able to articulate with non-statisticians to interpret and explain statistical findings.
Excellent organizational and problem-solving skills.
Proven leadership skills and must work effectively in a team environment.
Expertise in biostatistics procedures and alignment with regulatory requirements.
An ability to embrace the importance of teamwork and show strong interpersonal skills and accountability.
Must have demonstrated ability to be flexible and multitask in fast-paced, high-pressure, changing conditions.

Benefits

90% employer-covered benefits
Flexible PTO
A very generous holiday schedule that includes a week off in August and time off around the winter holidays
A well-stocked kitchen with snacks and beverages
Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Applicant Tracking System Keywords

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

Hard Skills & Tools

biostatisticsdata managementstatistical programmingstatistical analysisepidemiologic methodsSASstatistical analysis softwareclinical systemsregulatory complianceclinical trial design

Soft Skills

leadershipcommunicationpresentation skillsorganizational skillsproblem-solvinginterpersonal skillsteamworkflexibilitymultitaskingaccountability

Certifications

Ph.D. in StatisticsMasters in Statistics