JOB SUMMARY
Responsible for providing biostatistics support on one or more studies and/or projects. This individual is a key member of cross-functional study teams and contributes to: statistical aspects of study design, protocol development, and data collection; statistical analysis planning, oversight, and execution; interpretation of study results; and preparation of statistical aspects of clinical study reports and regulatory submissions. Provides input to the design and development of documents for clinical studies, including protocols, case report forms, statistical analysis plans, and clinical study reports. Participates in the selection of appropriate vendors or contractors for execution of the biostatistics and SAS programming elements of one or more clinical studies within a project. May interact with external vendors, key opinion leaders, and regulatory agencies as per study or program needs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Represents Biostatistics on study teams, provides high quality statistical input, contributions, and deliverables in a timely manner, and supports the biostatistics lead on a program
- Works independently with minimal supervision on multiple studies and/or projects in a flexible and agile manner, often under tight timelines, adapting as organizational needs and priorities change.
- Proactively identifies, communicates, escalates and resolves relevant issues and areas of concern, working closely with study/project teams and Biostatistics line management
- Collaborates with colleagues on cross-functional teams representing various departments (e.g., Statistical Programming, Data Management, Clinical Development, Clinical
- Operations, Pharmacovigilance/Drug Safety, Clinical Pharmacology, Medical Writing, Regulatory Affairs, etc.)
- Provides scientific and statistical contributions to study design, including selection of patient population, study objectives, endpoint definitions, sample size calculations and justification, and statistical methodology
- Contributes to formulation of relevant scientific questions for a study or project, translating these questions into statistical terms and clearly communicating statistical concepts and approaches to non-statisticians
- Calculates sample sizes/power for proposed studies, for alternative designs, and evaluates the advantages/disadvantages and timelines for various scenarios
- Ensures that proposed statistical analyses adequately and appropriately address study and scientific objectives and that study design and data collection support conducting the proposed statistical analyses.
- Manages and oversees biostatistics vendors and contractors, including production of statistical deliverables for clinical study reports (tables, figures, and listings, and supporting datasets/submission packages)
- Authors and/or approves statistical sections of protocols and clinical study reports, randomization specifications/schedules, statistical analysis plans, table/figure/listing shells, analysis dataset specifications, statistical aspects of publications (abstracts, presentations, and manuscripts), and statistical requirements for data collection within a project
- Reviews case report forms, edit check specifications, vendor data specifications, and other data management related documents to ensure data collected are appropriate to meet scientific and statistical objectives
- Leads study and/or project teams in the review and discussion of statistical analysis plans
- Responsible for supporting the biostatistics lead in responding to regulatory authority questions and in preparations for regulatory authority meetings
- Proactively develops knowledge and expertise beyond biostatistics by researching relevant medical literature and regulatory precedent to develop an understanding of the clinical, regulatory, and commercial context for a product’s development
- Respectfully challenges assumptions, thinking, and positions of colleagues and collaborators as needed in order to maximize the value of studies and development programs and to ensure statistical rigor
- Serves as a backup representative for the biostatistics program lead as needed
JOB QUALIFICATIONS
Education, Certifications, Experience
- Master’s degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 8 years (Senior Manager) or 10 years (Associate Director) of relevant experience in the pharmaceutical/biotechnology industry
- Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development
- Experience in developing innovative, creative, and practical solutions to various statistical/technical problems
Knowledge, Skills and Abilities
- Knowledge of pharmaceutical/biotech industry processes and procedures
- Knowledge of regulatory guidelines and requirements, including those from ICH, FDA, and EMA/CHMP
- Substantial knowledge of and experience with SAS programming, including:
- Clinical Data Interchange Standards Consortium (CDISC) standards for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets;
- Identification, investigation, and communication of data issues affecting statistical analyses; and
- Details of SAS procedures needed to execute statistical analyses
- Proficiency in nQuery/EAST sample size software packages
- Ability to oversee programming work performed by programming staff or vendors
- Excellent verbal and written communication skills and presentation skills
- Strong interpersonal skills, including ability to work well in a team environment and ability to interact with individuals at all levels of the organization
- Attentive to detail
- Demonstrated proficiency in project planning, management, and prioritization and in proactively anticipating, identifying, and proposing solutions to complex issues and problems
SPECIAL WORKING CONDITIONS
Office environment / Domestic and International travel up to 10% may be necessary
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
The expected salary range for this position based on the primary location in California is $175,000 to $215,000. Actual pay will be determined based on experience, qualifications, geographical location and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/careers-culture/who-we-are/
Vaccination Policy: Gossamer Bio is committed to complying with federal, state and local law on vaccinations. Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing [email protected], because Controller wishes to evaluate your candidacy for employment at Controller.
Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at [email protected].
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.
Top Skills
What We Do
Gossamer Bio is a San Diego-based company focused on the discovery and development of novel and differentiated therapeutic products, to address high unmet needs amongst various targeted patient populations. Founded by the former Receptos executive team, Gossamer Bio’s strategy will be to leverage an asset-rich in-licensing environment, with a focus on areas of high unmet need, utilizing a team with a strong track record of execution in immunology, inflammation, fibrosis and oncology.
