Principal Biostatistician

The Company:

Our mission is to improve the lives of people impacted by cancer by developing and commercializing innovative cancer therapies. We know how a cancer diagnosis affects a person and their family, and we are driven every day to improve outcomes for those who have received the diagnosis. We do this by driving adoption of our first FDA-approved breakthrough drug for appropriate patients with extensive-stage small cell lung cancer and by developing our robust, late-stage clinical pipeline assessing the potential for our medicine in a variety of tumors and cancer treatment settings. 

Our strategy leverages the experience of the G1 team and our deep experience in inventive and responsible drug development and commercialization. G1 provides a professional, diverse, inclusive, and creative working environment where individuals can thrive. We are driven to succeed by the patient communities we seek to help. We offer an opportunity to bring your best every day, and in doing so, profoundly help people living with cancer. Patients are waiting.

The Opportunity:

G1 Therapeutics is currently recruiting a Principal Biostatistician to join our team in Raleigh, NC or remote, reporting to Director, Biostatistics or above.  In the role of Principal Biostatistician, you will be responsible and accountable for providing statistical support for assigned clinical studies in collaboration with the clinical trial team with some supervision. You will work with compound lead statistician closely to advance one or two oncology compounds through different phases of development, regulatory filing, and drug product commercialization.

To be successful in this role, you must have good statistical knowledge in clinical trial designs with the experience of developing and implementing statistical analysis plan, and interpreting and reporting study results. You must also have demonstrated capacity in continued learning and applying of novel statistical methodology in the field of drug development.

Responsibilities:

• Responsible for all statistical tasks on the assigned clinical trials and perform these tasks independently with supervisor’s and/or peer’s review/input. Assist with protocol development and statistical design of a clinical trial, provide input to trial data collection, and review and approval of randomization specification. Responsible for developing and implementing Statistical Analysis Plan (SAP) and the implementation of the SAP by working with statistical vendor(s) and G1 statistical programmers closely. Contribute to results interpretations and reporting. 
• Provide statistical support for regulatory submission and commercialization activities as needed.
• Represent the Biometrics department on cross-functional teams for the assigned clinical studies. Responsible for seeking and achieving functional alignment and ensuring line function awareness of major activities for the assigned studies.
• Collaborate with other functions effectively. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements.
• Oversee statistical vendor’s deliverables and accountable for timeliness and adequate quality of all biostatistics deliverables for the assigned studies.
• Other duties as assigned

Requirements:

• PhD (in Statistics/Biostatistics or equivalent) with 3 years relevant work experience or MS (in Statistics/Biostatistics or equivalent) with 5 years’ relevant work experience.
• Have experience in providing statistical support for a clinical trial from design to completion, especially in development and implementation of an SAP and in support a Clinical Study Report. 
• Solid knowledge in statistics and its application to clinical trials; demonstrated problem solving skills and capacity in continued learning and application of novel statistical methodology.
• Proficiency in use of statistical software packages (e.g. SAS, R). Good knowledge of drug development and Health Authority guidelines.
• Demonstrated effectiveness working on cross-functional teams to achieve team objectives.
• Excellent project management and time management skills.
• Strong communication skills with the ability to collaborate well within Biometrics team and with non-statistical functions.
• Oncology clinical trial experience is a plus.

Why Join Us?

We know our employees are our most valuable asset, and our culture conveys that. All employees are issued laptops, and our office staff all have height-adjustable desks, access to a stocked kitchen, and multiple employee events throughout the year. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

An Equal Opportunity Employer

G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at G1 Therapeutics are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.