Astellas Pharma Director Safety Science Statistics in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Director, Safety Statistics opportunity in Northbrook, IL.
Position & Scope:
The primary purpose of this position is to provide safety statistical leadership in an objective and independent manner for programs in development (phases 1-to-3) under the remit of a Safety Assessment Committee (SAC). In this role, the statistician will be part of a multidisciplinary team that evaluates the totality of safety data available for a product's program on a regular basis to help Astellas determine whether an event or group of events meets the criteria for IND safety reporting to the FDA and all participating investigators. A strategically important part of the role played by this position is to perform unblinded comparisons of safety data in clinical studies.
The secondary purpose includes the provision of safety statistical expertise and leadership for postapproval programs that rely on primary and/or secondary safety data sources, both, traditional and real world. This role primarily exists in order to comply with FDAs "Guidance on Safety Assessment for IND Safety Reporting", dated December 2015. However in addition, the statistician will support PASS/PMR programs worldwide, for marketed products required by Health Authorities, and other programs that are Astellas driven, but not mandated by an Agency. In many instances, these programs will rely on the real world data sources, and the incumbent will be expected to engage and collaborate with various Divisions such as Development, Medical Affairs and Real World Informatics.
Essential Job Responsibilities:
- Provide strategic and scientific statistical leadership to SAC programs.
- Act as a key contributor in defining and driving the statistical strategy.
- Lead and be accountable for the safety statistical input and influence for SAC programs.
- Ensure effective partnership with other cross-functional members on the SAC, including the TA-level physician, clinicians who have general or specific safety experience, and other strategic members to drive the evaluation of accumulating safety data in order to enable Astellas to determine whether an event or a group of events meets the criteria for IND safety reporting.
- Drive quantitative decision sciences to enable SAC programs.
- Writes, or oversees the writing of, statistical analysis plans. Conducts, or oversees the conduct of, analyses to support SAC programs.
- Understand, identify, implement and support the use of safety analytic and graphics to evaluate aggregated data for ongoing safety review for an SAC program.
- Flexibly incorporate incoming data and quickly adjust one's approach to meet the objectives of the SAC.
- Quickly learn new disease areas along with treatments targeting those disease areas at a program level.
- Provide specifications on how the safety data should be integrated across studies for safety statistical evaluation, to ensure appropriate analyses and interpretation.
- Assists the Chairperson of the SAC in establishing and driving the functional strategy in terms of resourcing, technologies, processes, methodology, and standards to maximize efficiency.
For other PV work:
- Leads and drives safety statistical input to Risk Management and Benefit Risk Assessment work with the GSTATL.
- Provides strategic input and safety statistical support to observational studies for all therapeutic areas in PV.
- Works collaboratively with stakeholders in Development, Medical Affairs, and RWI to support Risk Management and Benefit Risk Assessment with safety statistical expertise.
- Provides safety statistical strategic inputs to observational research programs to support postapproval programs mandated by regulatory agencies and other observational studies that Astellas leads.
- Supports the safety statistical components of postapproval safety programs with purpose-oriented and proactive aggregate/integrated safety and benefit risk analyses planning, execution, and interpretation, working with the Lead Product Statistician.
- Ensures that safety statistical methodologies are acceptable to regulatory agencies and publications.
- Ensures acceptable statistical methodology, timely and accurate analyses, and appropriate presentation of results.
- Active participant in Benefit-Risk value tree creation/discussion and responsible for the appropriate BR analyses (Benefit Risk Product Assessment and relevant submission documents) using quantitative evaluation methodology, partnering with the GSTATL.
- Ensures compliance of function with SOPs, standards and all applicable regulations.
For the SAC:
- Direct impact on X preapproval programs that are in scope for the SAC.
- Approximate projected costs for a 3-year budget cycle for SAC programs include budgets in excess $1,850,000.
- The estimated revenue generation from a given product is between $10-500 million per year, per region.
For other work in PV:
- Advises approximately 40 postapproval product teams with strategic and tactical safety statistical input with impact to the programs.
- Supports regulatory compliance with mandated postapproval PASS/PMR/Risk Management studies, worldwide
For the SAC: To ensure the independence and objectivity of the role, the position will reside in the Risk Management/Benefit Risk function in Safety Science- PV. The position reports to the Exec. Director of Risk Management/Benefit Risk. Is a member of the Safety Assessment Committee (SAC). Closely collaborates with members of the SAC. Leads the safety statistical design and inputs on the scope of work under the SAC, and statistical deliverables.
For other work within PV that requires cross-divisional collaboration (RWI, Med. Aff): Serves as safety statistical expert on PV-led postapproval studies required by regulators. Provides guidance to PV stakeholders to support postapproval surveillance activities.
- M.S. or Ph.D. in statistics or equivalent.
- Minimum of 10 years experience in applying statistical methods in biomedical research: extensive pharmaceutical or CRO experience required with at least 3 years managing projects for a product or a therapeutic area; academic or regulatory assessor experience preferred.
- Extensive experience in conduct of meta-analysis which includes some applications within the Cochrane framework
- Experience applying Bayesian models in biomedical research
- Experience applying propensity score and/or instrumental variables within causal inference projects in biomedical research
- Experience in working on clinical project teams. Good understanding of entire drug development process - ability to see the "big picture".
- Experience as the independent lead statistician in a regulatory submission preferred in order to execute the mission for the role described in this job description.
- Advanced knowledge of statistical methods used in the industry to support analyses of clinical data, in order to execute the mission for the role described in this job description.
- Knowledge and skills in SAS or R required.
- Experience working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships.
- Ability to work in a matrix environment.
- Proven excellent organizational, project and time management skills.
- Very good oral, written, and presentation communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians.
- Very good problem solving skills.
- Accurate with a keen eye for detail. Dedication to quality and reliability in all work tasks.
- Ability to perform under pressure.
- Knowledge of relevant ICH, FDA, EMA, PMDA regulations and industry standards applicable to safety evaluation.
- Advanced knowledge of various health insurance claims and other automated healthcare databases as well as FDA AERs.Familiarity with databases used by Astellas' signal detection software (FAERS, VAERS, VigiBase ADR).
- Have familiarity with common RWD used by pharma.
- Familiar with methods such as disproportionality algorithms, data mining techniques (appears proprietary but literature likely exists), Bayesian Multi-item Gamma Poisson Shrinker (MGPS) and sector maps.
- Have strong expertise in applying causal inference methods to data from RWD
- Expertise in epidemiologic methods and meta-analysis.
- Experience in designing non-interventional designs including regulatory considerations.
- Ability to explore new mathematical models/methods to enable signal detection & safety surveillance.
- Experience with cross functional process improvement or innovation initiatives.
- Leadership skills and the ability to partner with other statistics and programming colleagues at Astellas and/or vendors employed by Astellas
- Knowledge of other statistical software preferred e.g., SQL.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled