Director of Biostatistics and Programming
3 weeks ago
Zymeworks is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative biotherapeutics. We are seeking a highly skilled Director of Biostatistics and Programming to join our team in Redwood City, CA. This is a hybrid role with a minimum of 3 days per week onsite.
Key Responsibilities
- Develop and implement strategic plans for the Biometrics group, ensuring alignment with corporate objectives.
- Grow and develop operations and management of biostatistics and statistical programming functional areas.
- Lead statistical aspects of projects, including experimental design, sample size estimation, subject randomization, statistical analyses, and data presentation.
- Ensure systems capabilities and resources are in place to optimize clinical and non-clinical data design, conduct, analysis, and interpretation.
- Plan, organize, and direct analysis work performed by staff and contract research organizations.
- Provide consultation with Clinical Development teams on study conduct, data management, statistical methodology, data analysis, and regulatory submissions.
- Develop and review statistical methods sections of study protocols, statistical analysis plans, statistical analyses, and statistical input to reports and publications.
- Review and approve study database specifications, data transfer plans, CDISC and ADaM specifications, and ensure reviews as needed by other key stakeholders.
- Interface with internal study teams and external data management, statistical, and programming vendors to ensure effective communications and vendor relationships.
- Recruit and select vendors, consultants, and contractors for data management, statistical, and statistical programming services.
- Oversee statistical and programming activities related to company programs, either internally or through management of outside contractors and/or CROs.
- Ensure adherence to quality control procedures for statistical programming activities.
- Develop Standard Operating Procedures (SOPs) and training guidelines for statistical and statistical programming activities.
- Work with project management to establish and ensure statistical, programming, and data management project deliverables meet expected timelines.
- Provide strategic guidance for biostatistics-related activities, regulatory activities, and oversight of contractors and/or CROs.
- Lead by example to foster effective and collaborative working relationships.
Requirements
- PhD in biostatistics, statistics, or a relevant scientific discipline, with a minimum of 8 years' related experience in the pharmaceutical industry.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
- Excellent organizational skills and the ability to manage concurrent deliverables in a challenging, milestone-driven environment.
- Knowledge of FDA, EMA, and ICH regulatory guidelines, clinical development process, clinical trial design, statistical programming, data analysis, and data management.
- Experience with regulatory agency interactions.
- Knowledge of SAS and other statistical programming packages.
- Strong math and analytical skills.
- Able to think and act strategically, anticipate roadblocks, and orchestrate plans to resolve issues and mitigate risks.
- Strong oral, written, and listening skills.
- Demonstrated high level of integrity and ethics.
- Proficiency with MS Office.
Total Rewards
Zymeworks offers a comprehensive total rewards package, including competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies. The base salary range for this role is $180,000 - $276,000 USD per year (US).
-
Senior Biostatistics Director
3 weeks ago
Foster City, California, United States Gilead Sciences Full timeBiostatistics Leadership Opportunity at Gilead SciencesWe are seeking a highly skilled Biostatistics professional to join our team at Gilead Sciences. As a Biostatistics Lead, you will play a critical role in the development of life-changing scientific innovations.Key Responsibilities:Lead biostatistical analysis and reporting for clinical development...
-
Senior Biostatistics Director
4 weeks ago
Foster City, California, United States Gilead Sciences Full timeJob SummaryWe are seeking a highly skilled Associate Director, Biostatistics to join our team at Gilead Sciences. As a key member of our Virology department, you will be responsible for providing statistical leadership and expertise to support the development and commercialization of our virology compounds.Key ResponsibilitiesProvide statistical leadership...
-
Biostatistical Analyst
4 weeks ago
Foster City, California, United States BioSpace, Inc. Full timeBiomarker Sciences InternshipWe are seeking a highly motivated and detail-oriented intern to join our Biomarker Sciences team. As a biostatistical analyst, you will contribute to high-impact projects that advance our company's mission to improve patient care.Key Responsibilities:Apply biostatistical and bioinformatic analysis methods to characterize assay...
-
Program Director
4 weeks ago
Redwood City, California, United States Stars Behavioral Health Group Full timeProgram Director OpportunityWe are seeking a highly skilled and experienced Program Director to lead our Mental Health Rehabilitation Center (MHRC) team. As a key member of our organization, you will be responsible for ensuring the delivery of high-quality clinical and operational services to our clients.About the RoleThis is a full-time position,...
-
Assistant Program Director
4 weeks ago
Redwood City, California, United States Caminar Full timeJob Title: Assistant Program DirectorJoin Caminar, a leader in providing innovative client-oriented mental health services, as an Assistant Program Director. In this role, you will assist managers with support and supervision of direct service staff, completing assessments, providing individual and family therapy, and training staff.Responsibilities:Complete...
-
Oncology Medical Director, MRD
4 weeks ago
Redwood City, California, United States Exact Sciences Full timeTransforming Cancer Care with Exact SciencesAt Exact Sciences, we're pioneering a new era in cancer prevention, detection, and treatment. As an Oncology Medical Director, MRD, you'll play a pivotal role in shaping our molecular residual disease (MRD) commercialization strategies. This is an exceptional opportunity to leverage your expertise in molecular...
-
Assistant Program Director
4 weeks ago
Redwood City, California, United States Caminar Full timeJob Title: Assistant Program DirectorCaminar is seeking a highly motivated and experienced Assistant Program Director to join our team. As a key member of our leadership team, you will be responsible for providing support and supervision to direct service staff, completing assessments, providing individual and family therapy, and training staff on...
-
Statistical Programming Manager
4 weeks ago
Foster City, California, United States Gilead Sciences Full timeJob Title: Sr. Manager, Statistical ProgrammingAt Gilead Sciences, we're committed to creating a healthier world for all people. As a Sr. Manager, Statistical Programming, you'll play a critical role in the discovery and development of life-changing scientific innovations.Key Responsibilities:Collaborate with Clinical Development staff to meet project...
-
Senior Manager, Statistical Programming Lead
3 weeks ago
Foster City, California, United States BioSpace, Inc. Full timeJob Title: Senior Manager, Statistical ProgrammingJob Summary: We are seeking a highly skilled Senior Manager, Statistical Programming to lead our Oncology Statistical Programming team. The successful candidate will be responsible for overseeing the development of statistical programming deliverables, collaborating with Clinical Development staff, and...
-
Senior Manager, Statistical Programming Lead
3 weeks ago
Foster City, California, United States BioSpace, Inc. Full timeAbout the Role:We are seeking a highly skilled Senior Manager, Statistical Programming Lead to join our Virology Therapeutic Area team. As a key member of our team, you will be responsible for leading the development of statistical programming deliverables for clinical trials in the Virology therapeutic area.Key Responsibilities:Collaborate with Clinical...
-
Marketing Director
4 weeks ago
Redwood City, California, United States Revolution Medicines, Inc. Full timeMarketing Director Opportunity at Revolution Medicines, Inc.Revolution Medicines, Inc. is seeking a highly skilled Marketing Director to join our team. As a Marketing Director, you will be responsible for developing and executing marketing strategies to support the launch of our lead RAS(ON) programs.Key Responsibilities:Develop and execute marketing...
-
Director of Operations
4 weeks ago
Redwood City, California, United States Snorkel AI Full timeJoin Snorkel AI as a Director of OperationsWe're on a mission to make machine learning practical for everyone, and we need your help to make it happen. As a Director of Operations, you'll be responsible for driving the planning, execution, and delivery of strategic data labeling and annotation projects and initiatives across various customers and...
-
Marketing Director
3 weeks ago
Redwood City, California, United States REVOLUTION Medicines Full timeMarketing Director Opportunity at Revolution MedicinesWe are seeking a highly skilled Marketing Director to join our team at Revolution Medicines, a clinical-stage precision oncology company. As a Marketing Director, you will play a critical role in developing and delivering marketing plans for our lead RAS(ON) programs in preparation for anticipated...
-
Director of Operations
4 weeks ago
Redwood City, California, United States Snorkel AI Full timeJoin Our Team as a Director of OperationsWe're on a mission to democratize AI by building the definitive AI data development platform.Our Journey So FarThe AI landscape has undergone significant transformation since 2016, when Snorkel AI started as a research project in the Stanford AI Lab. Today, we're at the forefront of generative AI breakthroughs.The Key...
-
Regulatory Affairs Director
4 weeks ago
Redwood City, California, United States Biomea Fusion, Inc. Full timeJob Title: Associate Director, Regulatory AffairsBiomea Fusion, Inc. is seeking an experienced Associate Director, Regulatory Affairs to support the company's regulatory affairs strategies for IND/CTA/BLA/NDA filings and approvals.Key Responsibilities:Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology...
-
Director of Financial Communications
4 weeks ago
Redwood City, California, United States Electronic Arts Full timeDirector, Corporate CommunicationsThe Director, Corporate Communications, will play a pivotal role in shaping EA's financial storytelling efforts, driving compelling narratives that position the company as a leader in the entertainment industry. This position will partner closely with the CFO and key business leaders to enhance all aspects of the Finance and...
-
Corporate Communications Director
4 weeks ago
Redwood City, California, United States Electronic Arts Full timeJob Title: Director, Corporate CommunicationsAbout the Role:We are seeking a highly skilled Director, Corporate Communications to join our team at Electronic Arts. As a key member of our Corporate Communications team, you will be responsible for advancing our financial storytelling efforts, positioning EA as a leader in the entertainment industry.Key...
-
Executive Director of Equity and Social Justice
4 weeks ago
Redwood City, California, United States San Mateo County Office of Education Full timeJob SummaryAs the Executive Director of Equity, Social Justice, and Inclusion, you will play a critical role in advancing the San Mateo County Office of Education's commitment to creating a more equitable and just educational environment. Under the direction of the County Superintendent of Schools, you will oversee and advance efforts to increase...
-
Senior Clinical Data Manager
4 weeks ago
Redwood City, California, United States Planet Pharma Full timeThe Opportunity:The Senior Clinical Data Manager is responsible for overseeing all aspects of the data management process, from project documentation to database lock of clinical trials. This role requires a broad knowledge of the data management process and the ability to plan, manage, and coordinate all Data Management activities for assigned studies with...
-
Senior Director of Corporate Communications
3 weeks ago
Redwood City, California, United States C3 AI Full timeC3 AI is seeking a seasoned Senior Director of Corporate Communications to spearhead the company's corporate communications efforts and drive impact through storytelling.This individual will develop and implement integrated corporate communications programs that focus on corporate reputation, thought leadership, and executive visibility, positioning C3 AI as...