- Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission.
- Direct or provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Lead the development of protocols, statistical analysis plans, and statistical programming plan.
- Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. May represent DSS on data monitoring committees. Build interdepartmental relationships.
- Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
- Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
- Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
- Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities. Build external scientific connections which foster professional development and promote the reputation of the Statistics department.
- Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. May represent DSS in discussions with regulatory agencies. Validate external statistical software to meet SOPs and regulatory requirements.
- MS (with 12+ years of experience) or PhD (with 8+ years of experience) in Statistics, Biostatistics, or a highly related field.
- High degree of technical competence and excellent communication skills, both oral and written
- Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
- Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
- Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs
-
Director, Statistics
5 days ago
AbbVie South San Francisco, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
-
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
-
Alumis Inc. South San Francisco, United States Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change t ...
-
BridgeBio Pharma, Inc. San Francisco, CA, United StatesAbout BridgeBio BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in geneti ...
-
Associate Director, Statistical Programming
1 week ago
Cargo Therapeutics San Carlos, United StatesJob Description · Job DescriptionCARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart c ...
-
Associate Director, Statistical Programming
1 week ago
Corcept Therapeutics Menlo Park, CA, United StatesCorcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.In 2012, we received FDA approva ...
-
Associate Director, Statistical Programming
3 weeks ago
Corcept Therapeutics Menlo Park, United States Full time· Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. · In 2012, we received FDA a ...
-
Associate Director, Formulation Development
1 week ago
Pliant Therapeutics, Inc. South San Francisco, United StatesPliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology a ...
-
BridgeBio Pharma Palo Alto, CA, United StatesBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in aca ...
-
Director, Emergency
2 days ago
AHMC Healthcare Daly City, United StatesOverview: · The Director of Emergency Department is the designated leader responsible for providing the overall leadership and direction for the Emergency Department. The Director has 24-hour responsibility and accountability for planning, organizing, developing, directing, coord ...
-
Director of Quality
2 days ago
AHMC Healthcare Daly City, United StatesOverview: · **JOB SUMMARY**: · The Director of Quality is responsible for directing all hospital-wide Quality, Infection Control, Performance Improvement, and Risk Management activities in accordance with external regulatory agency requirements, accepted standards of care, and in ...
-
Director Facilities
2 days ago
AHMC Healthcare Daly City, United StatesOverview: · The Director is responsible for the operation of the Facilities at Seton Medical Center and Seton Coastside including Engineering, Biomedical Engineering, Security, Telecommunications, and EVS. Responsible for guiding staff members in effective performance of their jo ...
-
Dir Materials Mgmt
1 week ago
AHMC Healthcare Daly City, United StatesOverview: · The Director of Materials Management is accountable for providing leadership which results in a cost effective, efficient, materials management function all in a manner. · **Responsibilities**: · **REQUIREMENTS**: · Major Job Objective and description of responsibilit ...
-
Manager, Behavioral Health
1 week ago
Sutter Health San Mateo, United States**Organization**: · MPHS-Mills-Peninsula Medical Center · **Position Overview**: · Accountable for leadership and supervision of the Outpatient Services which includes Partial Hospitalization and Intensive Outpatient Therapeutic Programs and others. In collaboration with the Dire ...
-
Maps Program Coordinator
1 week ago
Health Right 360 San Francisco, United StatesHealthRIGHT 360 gives hope, builds health, and changes lives for people in need by providing comprehensive, integrated, compassionate care that includes primary medical care, mental health services, and substance use disorder treatment. · **Benefits and perks**: · - HR360 offers ...
-
Area Director of Revenue Management
1 week ago
Hilton San Francisco, United StatesArea Director of Revenue Management - San Francisco · An Area Director of Revenue Management with Hilton coordinates Revenue Management processes and procedures for hotels in a designated geographical area to maximize overall room revenue. Manages and maintains group and transien ...
-
Business Intelligence Analyst
1 week ago
Autodesk San Francisco, United StatesJob Requisition ID # · - 24WD78069 · Position Overview · We're looking for a passionate and driven Business Intelligence Analyst to join our Customer Experience (CX) Analytics team. You will report into the Senior Manager of Business Analytics and partner with Product Managers ac ...
-
Institutional Giving Manager
4 days ago
Raphael House of San Francisco San Francisco, United States**Summary**: · Since 1971, Raphael House has been at the forefront of providing homeless and low-income families in the San Francisco Bay Area the personalized family-centered solutions they need to build brighter futures. Raphael House is a 100% privately funded and community-su ...
-
Episcopal Community Services San Francisco, United States**PRIMARY DUTIES AND RESPONSIBILITIES**: The Assistant Support Services Manager (ASSM) supports the Support Services Manager (SSM) in the oversight and development the Support Services program at a designated housing site(s) to provide intensive social work and support services t ...
-
Clinical Documentation Specialist
3 days ago
University of California San Francisco San Francisco, United StatesUnder general supervision of the Business and Program Development Director the database manager collects, collates, submits and presents clinical outcome data for PHC. This position is responsible for the management, analyzing, summarizing, and disseminating quality outcome repor ...
Director, Statistics - South San Francisco, United States - AbbVie
Description
Job Description
Job DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionPurpose
The Director, Statistics provides scientific and statitical leadership for assigned clinical development projects. A visible and collaborative role, the Diector works in partnership with clinical and regulatory experts to advance medicines to our patients.
Responsibilities
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
QualificationsQualifications
Key Stakeholders
Clinical development experts
Statistical programmers
Data science experts
Global Medical Affairs experts
Regulatory experts
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
