Position Title: Clinical Data Scientist
Aligos Therapeutics, Inc. is a biotechnology company located in South San Francisco, California that is developing novel medicines to treat liver diseases in virology and oncology. Aligos is pursuing the development of both oligonucleotide-based and small molecule therapeutics, each addressing major commercial market opportunities.
At Aligos, our science is the key to our success, and to improving patients’ quality of life. Our pipeline of developing novel compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the area of liver diseases. This is an exciting opportunity to become an early employee of a high energy, pre-IPO Research and Development company. We are looking for an enthusiastic Clinical Data Scientists who understands and appreciates the entrepreneurial environment of a “start-up” and who is willing to do what it takes to contribute to the success of the company.
The Clinical Data Scientist is responsible for overseeing the management of clinical data and the generation of key datasets and reports used for decision making and safety oversight of Aligos Therapeutics’ clinical development programs. This role will be responsible for the collection, storage, analysis, and reporting of all clinical data using outsourced clinical data management systems.
This position holder will work closely with each clinical development team at Aligos and with the biostatistician(s) and Data Management team(s) at our supporting CRO(s) to oversee the planning and implementation of data management activities.
In addition, they will help to coordinate and manage data outputs to enable multiple data monitoring and review activities such as dose escalation meetings and routine study safety oversight. This will involve developing fit for purpose customized outputs using tools such as JReview to enable decision making in a fast-paced dynamic small company environment. As such, this person will have an essential role in ensuring that the company can make critical decisions regarding the future direction of its programs on the basis of reliable, reproducible, accurate and current data sets. They will also play a key role in ensuring timely and accurate generation of high-quality data that will be used in clinical study reports, presentations and publications.
This person will report to the Head of Clinical Operations. Importantly, they will have an opportunity to shape the future nature of data related activities at a fast-moving company.
Essential Functions / Responsibilities:
- Participation in planning and design of clinical studies.
- Coordination and development of data management strategy.
- Liaison with CRO data managers and statisticians, ensuring oversight of: eCRFs development; EDC build and user acceptance testing; development of edit check specifications; reconciliation of external data sets with main clinical database; query generation and resolution; medical coding for drug safety assessment and other data quality related activities as required.
- Coordination of review of clinical data by clinical team.
- Development and coordination of data outputs to enable ongoing safety review and key decision making, using tools such as JReview.
- Reviews and develops transfer specifications with key vendors.
- Liaises with internal departments to coordinate key data integration activities within clinical datasets (e.g., pharmacokinetic, pharmacodynamic and exploratory research).
- Reconciliation of external data sets and oversight of database lock activities.
Required Education and Experience:
- A minimum of five (5) years in a pharmaceutical/biotech company or Clinical Research Organization (CRO) as a Clinical Data Manager.
- BS Degree or above
- Expertise in building electronic data capture systems such as Medidata RAVE, and in programming system edit checks
- Expertise in electronic case report forms, and data management plan development
- Strong project management, and written and verbal communication skills
- Experience of overseeing outsourced data management activities
Preferred Education and Experience:
- Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.
- Experience with JReview or similar program, highly desirable
- Experience with SQL programming desirable
- Strong data presentation skills
Additional Eligibility Qualifications/Competencies
- Must have excellent teamwork, communication, decision-making and organizational skills plus a good working knowledge and understanding of clinical trials.
- Must be proficient in the Microsoft suite of tools.
- Excellent communication, organizational, negotiation and interpersonal skills required.
- Ability to prioritize and handle multiple tasks.
- The successful candidate must be flexible and adaptable to the needs of a small company.
Work Authorization/Security Clearance
All candidates are expected to have authorization to work in the United States.
This position will require collaboration with contractors external to the company.
Position Type and Expected Hours of Work
This is a full-time position. Expected days and hours of work are Monday through Friday, 40 hours per week.
This position is located in South San Francisco and may require a limited amount of travel.
Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities and activities may change at any time with or without notice.
This position works in a standard office setting, in a facility that contains laboratory equipment.