Associate Director, Biostatistics

Gilead Sciences•Parsippany, NJ

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Associate Director, Biostatistics, you will provide strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area. You will represent Biostatistics at study management team and development team for multiple studies or programs, collaborate closely with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, Clinical Data Management to ensure high quality statistical planning, analysis, interpretation, and reporting. This may include, but is not limited to, providing statistical strategic input into study design, clinical development plans, sample size determination, protocol development, SAP authoring, TFLs and CSR review, and providing biostatistical input into scientific publications and presentations, and regulatory requests. In addition to clinical trials, you may lead or contribute to other activities that are non-molecule based, such as department strategic initiatives or working groups.

Requirements

Bachelor's Degree and 10 years’ experience OR Master's Degree and 8 years’ experience OR PhD /PharmD and 5 years’ experience

Nice To Haves

Demonstrated ability to rapidly assimilate scientific and statistical information.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Has advanced knowledge of biomedical statistical analysis, as evidenced by independence in designing, implementing and managing multiple statistical analysis strategies, plans deliverables and resource management.
Has advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results.
Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
Solid understanding of drug development phases and the nature of associated clinical trials across phases.
Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
Strong written and verbal communication, collaboration and organizational skills.
Experience in HBV and HIV programs is preferred.
Familiar with innovative trial designs
Proven effectiveness managing projects and teams.

Responsibilities

Serve as lead statistician for Phase 1–3 clinical trials with responsibility for overall statistical strategy and delivery
Acts as biostatistics lead on clinical studies or other non-molecule projects.
Represent Biostat on study management teams and development teams, providing strategic statistical leadership, and collaborate closely with other Biostatistics team members and cross-functional team.
Provides statistical consultation on trial design, endpoints, analysis methods, and authors statistical analysis plans
Overseas and lead all technical and operational statistical activities for a group of clinical trials.
Directs internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products.
Contribute strategic statistical leadership to cross-functional clinical development planning and protocol development.
Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring to inform development decisions
Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret historical and external data to derive useful information for clinical development.
Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
May participate in or lead special projects that can benefit multiple Biostatistics team members, such as innovative methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation.
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.