Associate Director, Data Management Science OperationsLocation San Rafael, California Workstyle Open to Hybrid Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
BioMarin Data Science is responsible for designing, capturing, analyzing, and presenting data that can drive key decisions for Clinical Development, Medical Affairs, and other business areas of BioMarin. With a quality-by-design culture, Data Science builds quality data that is fit-for-purpose to support statistically sound investigation of critical scientific questions. The Data Science team develops solid analytics that are visually relevant and impactful in supporting key data-driven decisions across BioMarin.
The Data Management Science (DMS) group contributes to Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation levels following international standards and GCP. The DMS Operations sub-function is responsible for the efficient and effective delivery of complete, correct, and consistently fit-for-purpose data sets for statistical analysis across all clinical development and post-approval programs. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program-related data management activities such as: protocol review, Case Report Form (eCRF) development, Data Management Plan development, Data Validation Plan development, requirement specifications, reconciliations, and data quality validation activities.
Hybrid: San Rafael or Brisbane offices
The DMS Operations Associate Director role is responsible for all for all study-related data management activities, including protocol review, eCRF development, Data Management Plan development, Data Validation Plan development, reconciliations, and the delivery of complete, correct, and consistently fit-for-purpose study data sets for statistical analysis.
The Associate Director may also act as Process Improvement / Departmental Initiative Lead, as needed.
DMS Operations Associate Director may perform a range of the following responsibilities, depending upon the studies’ complexity and studies’ development stage:
Program Planning and Execution:
- Complete all study Data Management activities and deliverables, including (but not limited to):
- Ensure Data Management colleagues and Data Science colleagues are engaged in study startup activities by facilitating appropriate project management activities, such as kick off meetings, timelines, other relevant communications
- Conduct protocol review and raise any data collection considerations affecting data quality, reliability, or suitability for statistical analysis
- Define Case Report Form (eCRF) in concise, self-explanatory, and user-friendly format. Collaborate with study team colleagues to ensure eCRF completion guidelines/instruction are accurate
- Develop and facilitate approval of Data Management Plan outlining key data management activities and deliverables
- Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan
- Collaborate with Clinical Programming and Database Development colleagues to ensure that database build occurs in accordance with specifications and timelines
- Execute appropriate ongoing/periodic Data Validation activities in collaboration with Clinical Programming, including reviews of data listings, discrepancies, and the related follow-up on management of queries with investigators
- Conduct the identification, investigation, and resolution and/or escalation of study and program data issues, as appropriate
- Oversee and facilitate medical coding activities
- Collaborate with Clinical Programming on the development and execution of data transfer specifications
- Collaborate with Clinical Programming and BioMarin Pharmacovigilance (BPV) on SAE reconciliation activities
- Complete pre-database lock or snapshot checklist activities and related Data Validation meetings with cross-functional stakeholder to approve the DB lock/snapshot go ahead
- Develop and deliver regular updates to leadership on key program risks, issues, and milestones
- Oversee Trial Master File update for all Data Management deliverables
- Ensure compliance with Regulatory Guidelines (e.g., FDA, ICH) across all study-related DMS activities
- May represent Data Management as a member of the relevant study team (e.g., clinical Study Execution Team (SET) or post-approval Medical Affairs Program Team (MAPT) or Study Team (MAST)
- May lead a Data Working Group to investigate, diagnose, and resolve study data issues; lead the cross-functional review of data management deliverables: CRF, edits checks, DM plan
- May lead all data collection and management-focused meetings with cross-functional partners/stakeholders: Data Science colleagues, CLO, GMAF CLS, BPV, Project Management, Compliance, and Regulatory
- Participate in Data Analysis and Review Team (DART), when appropriate, to discuss Data Management deliverables and activities
Subject Matter Expertise
- Participate in initiatives aimed at expanding Data Science and Data Management capability in a designated area of expertise, such as CDISC/CDASH, central labs, local labs, ePro, imaging, RWE, etc. by building best practices in processes, tools, templates, or other guidance for the subject area
Education & Experience
- PhD or MA degree preferred; orBA/BS degree with a focus in data science, statistics, computer science, life science, or related scientific discipline
- 3+ years of experience in clinical development, including technical experience within and outside of Data Management Science, with PhD; or5+ years with MS; or 8+ years with BS
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.