Executive Director of Biostatistics (Inflammation)
Gilead Sciences, Inc.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Inflammation will lead the Biostatistics function within Inflammation Therapeutic Area (TA), and oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions in the TA. The ideal candidate will have a proven track record of functional leadership, strategic situational judgement in using both innovative and pragmatic statistics, as well as demonstrated motivation for and excellence in people management and development.
This role is an onsite opportunity at our global headquarters in Foster City, CA.
Responsibilities
+ Provides statistical oversight of all biostatisticians in the TA and all biostatistics-related work conducted by internal biostatisticians and external consultants for the TA.
+ Provides strategic inputs and statistical expertise for clinical development programs. Partners and collaborates with cross-functional TA leads to meet the regulatory, scientific and business objectives.
+ Oversees and contributes to the completion of all technical and operational statistical activities in the TA through management of internal and external resources.
+ Anticipates emerging projects in the TA and works with senior management to develop staffing plan. Properly assigns and manages resource according to priorities and development strategies.
+ Negotiates project timelines across programs with competing priorities given constraints. Manages and coordinates limited resources to produce quality deliverables within timelines.
+ Ensures adherence to SOPs, BEDs, and all departmental standards and processes regarding the conduct of clinical trials, statistical methodology, data analysis and interpretation.
+ Champions the development and training of decision-enabled statistical tools. Explores opportunities for more efficient and innovative statistical approaches.
+ Responsible for ensuring scientific integrity of the statistical methodology applied to clinical trials. Accountable for ensuring rigorous statistical approaches implemented in the TA.
+ Encourages and empowers biostatisticians to exercise good judgement, embrace data-driven approach, and follow the best practices and principles to become accountable decision-makers.
Capabilities & Requirements:
+ Excellent verbal and written communication skills. Excellent negotiation and interpersonal skills
+ In depth knowledge of the drug development process. In depth knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance.
+ Proven ability to supervise team leads who supervise personnel. Ability to delegate, coach, and provide feedback and career development opportunities to team-members.
+ Ability to provides team-members with a framework for decision-making that delineates the actions associated with the decisions made under the framework and recognizes that appropriate actions taken in the present impact the chance of positive outcomes in the future.
+ Excellent judgment and problem-solving skills in complex situations. Ability to identify the most important aspects of an issue. Ability to make effective evidence-based decisions even when information is limited, or solutions may produce unpleasant consequences in the short term.
+ Ability to provide overall leadership for one or more departmental strategic initiatives. Ability to assess need for changing processes, and to recommend and implement new infrastructure and/or processes to improve efficiency and quality.
+ Ability to integrate planning efforts across departments to ensure organizational effectiveness. Ability to drive change and influence decision making.
+ Ability to advise and influence senior leadership/functional leads on biostatistics strategies as well as functional issues that have a business impact. Ability to use competitive intelligence to influence clinical development strategies.
+ Inflammation drug development experience is required, including the design and conduct of clinical studies from early through late stage development and regulatory interactions.
+ PhD degree in Biostatistics or equivalent and minimum 15 years of industry experience is preferred.
**More specific responsibilities for Biostatistics TA Head**
+ Participate in DRC and other TA-lead-level cross-functional meetings, and represent Biostatistics function.
+ Conduct regular TA meetings and disseminate TA information within the Biostatistics team, and with other functions as needed.
+ Provide clarity on expectations for all biostatisticians within the TA, including delegation, decision-making, and communication framework. Provide constant constructive feedback accordingly.
+ Develop talent action plans to ensure retention of (top) talents. Anticipate upcoming challenges, identify potential capability gaps, and utilize internal/external resource to bridge the gaps.
+ Coordinate processes, training and other managerial activities with BLT members. Assess and address potential compliance risks and ensure audit/inspection readiness within and across TAs.
+ Participate in Biostatistics leadership meeting and other department-related meetings. Keep Head of Biometrics informed with major development in the TA.
The salary range for this position is: $302,005.00 - $390,830.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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