Data Analytics Leader

Software Guidance & Assistance, Inc., (SGA), is searching for a Data Analytics Leader for a CONTRACT assignment with one of our premier Pharmaceutical Services clients in South San Francisco, CA.

Responsibilities:

• Collaborate closely with RBQM Strategic Leads and other RBQM workgroup members to operationalize the integrated Quality Risk Management Plan (iQRMP), and to manage the identification of critical-to-quality (CtQ) factors, development of risk control strategies, and implementation of risk mitigation activities.
• Collaborate with the global RBQM Center of Excellence (COE) to drive the design and improvement of technology and analysis solutions necessary for RBQM implementation within the firm, including in-house systems and potential external technologies.
• Support RBQM Strategic Leads and study teams in selection, set up and maintenance of reports for Key Risk Indicators (KRIs), Quality Tolerance Limit parameters (QTLs), and other applicable assessments and dashboards, ensuring consistency by adopting applicable global standards.
• Lead and perform peer reviews and QC of the ECD specific setup of KRIs and QTLs vs iQRMP and system specifications, as required.
• Support study teams to conduct data surveillance and issue management by defining consistent risk control strategies and acceptable risk limits in collaboration with the RBQM Strategic Leads and other RBQM workgroup members.
• Deliver timely and high-quality risk-based monitoring analytics and support.
• Provide training and knowledge sharing to study teams to promote RBQM analysis solutions and best practices.
• Lead centralized systematic data surveillance across studies in ECD, document surveillance activities, and assess control measure outputs for necessary mitigating actions.
• Analyze data for meaningful trends, trigger mitigating actions, and identify potential issues for knowledge sharing across studies.
• Ensure inspection readiness for the ECD specific RBQM analysis solutions.
• Champion RBQM within the company and collaborate with cross-business unit RBQM SMEs in continuous improvement and development of risk management processes and system as needed.

Required Skills:

• Bachelor's degree in Data Science, Statistics, Computer Science, Life Sciences, Public Health, or a related field. Master's degree preferred.
• 5 years experience in Biotech/Pharmaceutical industry with knowledge of the pharmaceutical/biotech clinical development process
• 7 years experience in Analytics or Statistics (5 years of experience with a Masters degree)
• 3 years of experience in RBQM / RBM processes, including awareness of industry strategy and direction, knowledge and understanding of ICH E8 and ICH E6 requirements
• Strong proven experience using data driven methods to analyze and solve business situations, strong critical thinking and analytical skills and aptitude for data analytics including mathematical and statistical concepts
• Strong systems awareness including good knowledge of data pipelines, models and systems along with strong cross-functional inputs and dependencies contributing to end to end RBQM delivery
• Proficient in data analysis tools (e.g., R, Python, JMP) for manipulating, analyzing large datasets, creating visualizations, and applying statistical methods (hypothesis testing, regression analysis, data modeling) to analyze clinical trial data
• Proficient in data visualization tools (e.g., Tableau, Spotfire)
• Experience and understanding of clinical trial data from various sources (e.g. Veeva, RAVE, IRT, SDTM, clinical devices, etc)

Preferred Skills:

• Strong organizational skills and attention to detail
• Strong interpersonal skills and a consultative mindset, with the ability to develop strong partnerships, highly effective verbal & written communication skills
• Good problem-solving ability, process minded, breaking down complex problems into distinct parts, able to generate refined output from general concept, managing uncertainty, understanding, anticipating interdependencies
• Able to proactively "connect the dots" by asking thought-provoking questions
• Objective when presenting insights and guiding decision-making; demonstrate good presentation skills by pairing sound analytics with storytelling
• Self-accountability, strong sense of responsibility, and integrity
• Able to multi-task and re-prioritize work on short notice, able to lean in and manage through change
• Ambitious, resourceful, works with minimal instruction and oversight
• Highly effective leader and team player

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.