Director, Biostatistics

Summary

Join Generate:Biomedicines as the Director, Biostatistics, providing statistical leadership in clinical development and regulatory submissions. You will design and execute complex global development projects, interpret results for team members, and supervise contract biostatisticians. Responsibilities include partnering with various scientific teams, ensuring statistical integrity, preparing presentations and reports, and implementing statistical techniques. The ideal candidate possesses a PhD or MS in statistics/biostatistics with extensive pharmaceutical industry experience, expertise in statistical software, and a deep understanding of clinical trial designs. This role requires strong communication and leadership skills, and the ability to work effectively in a fast-paced environment. Generate:Biomedicines offers a collaborative and innovative environment to contribute to groundbreaking biomedicines.

Requirements

• PhD or equivalent degree in statistics/biostatistics with >8 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >10 years’ experience
• Prior statistical leadership or significant contribution to at least one late stage (Phase 2b and beyond) study
• Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies
• Capability to provide statistical leadership to cross-functional teams at the protocol and project level
• Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills
• Expertise in statistical software such as R or SAS is required
• Deep knowledge of statistical methodologies for clinical trial designs, including adaptive, Bayesian, and platform trials, and analysis of various types of endpoints data
• Skilled in clinical trial simulations, including designing and interpreting complex simulation studies
• Providing statistical support and oversight for one or more clinical projects
• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-statistical and statistical audiences
• Driven for results with demonstrated interest and ability to welcome new challenges, embrace changes, take initiative, and find solutions to technical problems
• Demonstrated ability and interest to learn multiple disease indications, endpoints and appropriate statistical/regulatory requirements

Responsibilities

• Serve as a key statistical leader guiding clinical development strategies and regulatory submissions, acting as a subject matter expert in statistical design and methodology while driving cross-functional alignment on statistical strategy
• Represents Biostatistics at Project and Study team meetings. Interacts with Clinical Development, Regulatory Affairs, Statistical Programming, Data Management, Translational Medicine, Clinical Pharmacology, Clinical Operations and others to design clinical trials, as well as ensure the clinical program is well executed through appropriate analyses
• Analyze data and interpret results from clinical trials to meet the project objectives; may work on exploratory analyses related to clinical pharmacokinetic/pharmacodynamic, translational biomarker, and/or manufacturing data
• Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management
• Apply and implement basic and complex statistical techniques independently to assigned projects
• Assist in the oversight of data flow and transfers to ensure timing and quality of data collection as well as data reporting
• Work with Statistical Programming to ensure programs meet analysis requirements, internal SOPs, and external regulatory requirements
• Oversee the activities of statistical service providers, as appropriate
• Serves as an SME in the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc
• Identifies the need for new process improvement initiatives, and leads working groups to solve the process gaps. Sets timelines and expectations for the deliverables
• Identifies the need for new statistical methodology and keep abreast of new developments in statistics, drug development, and regulatory guidance to establish required methodology

Preferred Qualifications

• Some experience in Covid/vaccine/ respiratory immunology and/or oncology therapeutic area research and development is preferred
• Successful contribution to regulatory submissions (e.g., BLA, MAA) and interactions with health authorities