/ /Statistical Consultant, BiostatisticsJob Summary
This is expected to be 20 hours/week.
The Statistical Consultant, Biostatistics will support clinical development programs for the Biostatistics function within the Data Science Department (covering Biostatistics, Clinical Data Management, Statistical Programming, Study Endpoints, & HEOR). The role will be charged with oversight of the statistical aspects of assigned product development programs. In particular, the design, analysis, and reporting of individual clinical trials and regulatory submissions (e.g., Summary of Clinical Efficacy) are the key responsibilities of the Biostatistics function. In addition, the Biostatistics function works collaboratively with adjacent functions in the design and implementation of eCRFs, ePRO diaries, risk-based monitoring plans, regulatory meeting packages, publication plans, etc. This role in Biostatistics provides relevant input to project management, approval of deliverables from CROs or external business partners, and coordination of internal reviews. Lastly, there are diverse opportunities to lend statistical expertise to projects arising in Drug Safety, Marketing, Corporate Development, and other areas beyond clinical development, as needed.
As an individual contributor, the role will also provide timely and efficient management of individual clinical trial conduct, analysis, and reporting (Phases I to IV); lead the collaborative process for clinical study designs, relevant sample size selections and statistical analysis methods; produce key results and sensitivity analyses leading to the authoring of clinical study reports, especially the inferential conclusions; manage external vendors providing analysis and reporting; prepare material for and present at Investigator Meetings; coauthor primary and secondary manuscripts of clinical trial results.
* Evaluate information from the statistical literature, relevant government agencies, and outside experts relevant to assigned projects and special topics;
* Contribute to the development of clinical trial processes that adhere to GXP principles and best practices;
* Promote and integrate statistical methods into product development programs;
* May serve as statistical liaison with CROs and third party data vendors;
* Review and approve clinical protocols and clinical study reports including authorship of key sections (sample size, methods, missing data, etc.) and conclusions;
* Ensure that protocols and statistical analysis plans are followed throughout the course of analysis and reporting - documenting assumptions, decisions, changes, and conclusions;
* Set and manage biostatistics timelines within assigned clinical studies;
* Programmatically QC the key SAS program deliverables for any relevant clinical studies; Or may provide independent SAS programs for key analysis outputs;
* Contribute to analysis and reporting standards, and worktools that facilitate the implementation of standards when needed;
* Follow and enhance quality system applicable to best statistical practices and FDA expectations per ICH guidance (e.g., author and update SOPs, as requested by Data Science management).
* Advanced degree in biostatistics, statistics, or related field (e.g., pharmacometrics) as well as experience in a regulatory environment within biopharmaceutical product development;
* Minimum 6 years of relevant pharmaceutical/biotechnology experience;
* Knowledge of linear models, including repeated measures analyses and mixed effects models as well as categorical data analysis required; experience with time to event data and exact methods desirable;
* Experience in late-phase pivotal trials, post-approval trials, and/or registries;
* Experience in providing statistical input into protocol study design, writing analysis plans, and the regulatory and scientific reporting of clinical research;
* Relevant knowledge in supporting Phase 1 studies as well as early-phase studies to support development program decisions ("go/no go") and dose selection;
* Proficiency in SAS programming;
* Demonstrated proficiency initiating and managing clinical trials as well as outsourcing trials and programs;
* Knowledge of, and experience with CDISC standards, medical terminology, FDA regulatory process (e.g., "milestone" meetings), and applicable ICH guidelines;
* Good organizational and problem-solving skills;
* Detail-oriented with strong quantitative, written, and communication skills;
* A person who can understand and clearly communicate complex information;
* Excels in a collaborative team-oriented environment;
* Must be able to manage multiple initiatives and shifting priorities within a small company environment;
* Occasional travel.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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