United States flag

Sr. Statistician

United States - Maryland - Frederick, United States - California - Santa Monica, United States - California - Oceanside, United States - California - El SegundoProcess/Product Development & OperationsRegular

Job Description

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

Kite is seeking a highly motivated individual to work on innovative CAR-T cell therapy for cancer

treatment. As a Senior Statistician II in the Statistical Sciences & Analytics (SS&A) group of Network

Manufacturing Sciences and Technology (NMSAT), you will identify, develop and implement statistical methods to support new product introductions and GMP manufacturing for Kite’s engineered autologous T cell therapy products. The Sr. Statistician will also help establish a statistics center

of excellence to create statistical standards and harmonize statistical methods across Kite using industry guidance and best practices.

Key Responsibilities include:

• Identify, evaluate and apply appropriate statistical methods for study design and analysis of data related

to process validation, tech transfers, process monitoring, investigations, analytical method performance,

and product performance

Support the development of final product, in-process and raw material specifications

• Consult and defend statistical approaches used in regulatory filings, response to questions, and

regulatory inspections

• Present analyses and proposed statistical / analytical strategies in a variety of cross-functional forums

• Author internal technical reports, position papers, and contribute to content for regulatory submissions

• Assist with coaching, mentoring, and training of data analysts and non-statisticians on the appropriate

use of statistical methodologies and statistical software for their business processes

Contribute to department policies and procedures in support of establishing of a statistics center

of excellence to harmonize and align on statistical tools and methodologies across Kite using industry

guidance and best practices

Develop and promote the use of advanced statistical methods, e.g., Bayesian methods or

predictive analytics, that contribute to a competitive advantage for Kite within the broader market

• Affect statistical practices in the cell therapy industry through external meetings and conferences

Basic Qualifications:

• PhD 0+ years’ experience OR

Master’s Degree and 6+ years’ experience in biotech / biopharma, high-tech industries OR

• Bachelor’s Degree and 8+ years’ experience in biotech / biopharma, high-tech industries OR

• High School Degree and 12+ years’ experience in biotech / biopharma, high-tech industries

Preferred Qualifications:

• Advanced degree (MS or PhD) in applied or industrial statistics highly preferred, with proficiency in Design of Experiments, Statistical Quality Control, advanced modeling and simulation, Bayesian methods,

and multivariate methods. Knowledge of Machine Learning, NLP or AI, is a plus.

• 2 + years’ experience in a technical role in the biotech / biopharma industry or other high-tech industry

• Chemistry, Manufacturing and Controls (CMC) experience in gene or cell therapy is preferred

• Proficiency in SAS, SAS Viya, JMP and R with a demonstrated experience of implementing statistical concepts into ready-to use software

• Practical experience with cGMP manufacturing and regulatory regulations for CAR-T cell products or pharmaceuticals

Excellent scientific background and ability to drive data driven decision making within

technical organizations and to engage, challenge and extend complex methodological topics,

and interact with other statisticians on statistical-methodological issues for complex projects

Excellent communication skills to effectively communicate the findings of analyses with others in their organization; this includes both verbal and written communication, as well as the ability to present data in easy-to-understand, visual ways

Excellent interpersonal skills and the ability to interact effectively with internal and external stakeholders across different functions

• Fluency in written and spoken English with excellent writing, presentation, and teaching skills

• Ability to function efficiently and independently in a changing environment

Adaptable and comfortable in a collaborative and inclusive company environment

• Ability to lead a cross-functional and diverse team while fostering inclusion

Creative and thoughtful problem-solving skills

The salary range for this position is: $139,995.00 - $181,170.00. 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.


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France:

Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com