Biostatistician

Job Description

As Principal Biostatistician, you will serve as the blinded study statistician on client studies and as the founding technical owner of this service line. You will own all aspects of the statistical work, set the standards, and help decide how the function grows. You will work from clean, locked data provided by the sponsor’s or CRO’s data management team, so you must be comfortable defining data transfer specifications and handoffs with outside partners.

Key responsibilities Study design and protocol development

• Advise sponsors on trial design, including classical, adaptive, seamless, and Bayesian approaches

• Perform sample size and power calculations and document the justification

• Define primary and secondary endpoint strategies and select appropriate analytical models

• Review protocols for statistical soundness and feasibility Statistical analysis planning

• Author Statistical Analysis Plans (SAPs), including analysis populations, estimands, missing data handling, sensitivity analyses, and multiplicity

• Develop TLF shells (mock tables, listings, and figures)

• Write randomization specifications and coordinate schedule generation with the unblinded statistician and IRT/IWRS vendors Statistical programming and CDISC standards

• Develop and oversee SDTM and ADaM datasets that meet FDA data standards requirements

• Run conformance checks (e.g., Pinnacle 21) and resolve findings

• Write, test, and independently validate analysis programs and macros in SAS and/or R

• Produce final TLFs according to the approved SAP and shells

• Establish programming standards, validation SOPs, and a controlled, compliant programming environment Interim analysis and safety monitoring

• Serve as blinded study statistician, and write the statistical sections of DSMB charters and interim analysis plans

• Develop validated DSMB report programs and blinded (open-session) outputs, which the unblinded statistician runs on unblinded data

• Design and run centralized statistical monitoring to detect site-level anomalies, outliers, and patterns of protocol deviations Final analysis and regulatory support

• Lead final statistical analyses and interpret the results

• Perform integrated summaries of safety and efficacy (ISS/ISE) across studies

• Prepare submission-ready datasets and supporting documentation (e.g., define.xml, reviewer’s guides)

• Draft statistical responses to health authority questions (e.g., FDA)

• Write and review the statistical sections of Clinical Study Reports Client and business development

• Act as the statistical point of contact for sponsors during scoping and delivery

• Support proposals with statistical scope, assumptions, and effort estimates

• Present capabilities and approach at sponsor meetings Function building

• Write core biostatistics SOPs (SAP development, programming validation, randomization, and unblinded firewall and access control)

• Manage the separate unblinded statistician resource, including scope, contracting, and adherence to firewall procedures

• Identify and manage contract statisticians, programmers, and specialist partners (e.g., pharmacometrics) as volume grows

Skills and Requirements

• PhD in Biostatistics or Statistics with a minimum of 5 years of industry experience
• Direct experience as lead statistician on Phase II–III interventional trials
• Proven experience authoring SAPs and supporting at least one regulatory submission
• Expert SAS programming; R proficiency strongly preferred
• Working knowledge of CDISC SDTM, ADaM, and define.xml
• Working knowledge of ICH E9 and E9(R1), and ICH E3 as it applies to statistical reporting
• Experience supporting DSMBs, including charter development and blinded or open-session reporting
• Ability to explain complex statistics to clinical, operational, and commercial audiences
• Experience with adaptive or Bayesian designs
• ISS/ISE experience
• Experience interacting directly with FDA or other health authorities
• CRO or consulting background, with comfort managing multiple sponsors at once
• Therapeutic area experience relevant to Ambit’s portfolio [e.g., rare disease, nephrology, oncology, immunology]
• Experience setting up statistical SOPs or a new function

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].