Head of Biostatistics
Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
Contributes in study level tasks from statistics perspective: selection of study design, selection of end points to meet research objectives, sample size and power calculation, and analyses methods. · Develops or review SAPs, TLF shell and specification, and review CRF's and other study documentations · Performs ad hoc statistical analyses, including the statistical programming, for assigned studies; interprets data and provides statistical input to clinical protocols, Clinical Study Reports (CSR). · Lead and/or manage both in-house and CRO activities related to statistical analysis, programming and data management. · Performs simulations to create mock analyses. Proposes new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results. · Interacts with staff from other operational groups (clinical research, clinical OPs, marketing and preclinical).
Develops biostatistics and data management SOP's. · Provides effective guidance and communicates to CRO staff in the production of tables, figures, and listings. · Reviews and validates analysis data sets, tables, figures, and listings. · Reviews database design, CRF's, and edit checks. · Attends FDA advisory committee meeting. · Reviews and prepares Integrated Safety (ISS) and Integrated Summary Efficacy (ISE). · Reviews CDISC/SDTM and DEFINE.XML. · Attends Operations meetings, keeps up-to-date on project issues companywide, and keeps Director informed of project issues. · Works under limited supervision. · Assists with other duties as assigned. · Interacts with clients as needed for project and/or relationship management. Non-Essential Duties & Responsibilities: ·
Supervisory Responsibilities: · Provides oversight to the data capture and management, and database requirements.
Ph.D. with 6+ plus years of experience or MS in Biostatistics with 8+ for Associate years of experience in the pharmaceutical/CRO (Associate) , including significant interactions with regulatory bodies and experience in central nervous system indication preferred. · Experienced in NDA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction. · Broad knowledge and superior understanding of advanced statistical concepts and techniques with experience in adaptive designs, longitudinal data analysis, handling missing data using pattern mixture models, sensitivity analysis. · Fluent in SAS data step programming including SAS macro, familiarity with other packages . · Familiarity with ICH guideline and FDA other regulatory authority guidance. · Excellent written and oral communication skills including grammatical/technical writing skills. · Excellent attention and accuracy with details. · Familiarity with statistical methods that apply to Phase I-IV clinical trials. · Strong organizational skills. · Ability to solve moderately complex problems (identify, propose & implement solutions). · Ability to work in team situations. · Demonstrated strong individual initiative. · Ability to effectively manage multiple tasks and projects. · Ability to lead and co-ordinate the work of small teams. · Ability to work in a fully self-directed manner
• Commitment to ethical scientific investigations and rigorous experimental methods.
• Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
• Sense of urgency in performance of duties.
• Interpersonal skills that promote a collaborative and productive lab environment.
• Effective and efficient written and oral communication skills.
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.