Director Biostatistics

The Opportunity:

G1 Therapeutics is currently recruiting an Director, Biostatistics to join our team reporting to the VP of Biometrics. In the role you will serve as a compound lead statistician for one or more oncology compounds in clinical development and be responsible and accountable for all statistical aspects for the assigned compound’s development throughout development phases and regulatory filing activities.

To be successful in this role, you will have proven experience providing strategic input in collaboration with other functions in identifying an efficient path to advance pipeline compound(s). The successful candidate is also expected to have solid statistical knowledge in clinical trial designs and data analysis, and is proficient in explaining statistical approaches, interpreting and reporting of trial results. The successful candidate initiates, drives and implements appropriate and novel statistical approaches that result in drug development efficiency. The... successful candidate is also expected to have demonstrated capacity in continued learning and application of novel statistical methodology in the field of drug development.

Responsibilities:

• Responsible for all statistical aspects in supporting the assigned compound’s development from general development plan to individual study design and implementation.
• Initiate, drive and implement novel methods and innovative trial designs in alignment with the Project team.
• Lead statistical aspects of submission activities and responsible for delivering scientifically and statistically sound regulatory documents; meetings with and responses to health authorities and provide statistical support to other drug development and commercialization activities, as needed.
• Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
• Represent the Biometrics department on cross-functional teams for the assigned compounds. Responsible for seeking and achieving functional alignment and ensuring line function awareness of major activities throughout the phases of assigned compound’s development.
• Collaborate with other line functions effectively and contribute as an integrated member in driving informative decision making.
• Explain statistical concepts and interpret study findings in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements.
• Establish and maintain sound working relationships and effective communication within the Project Team and Biometrics organization.
• Oversee statistical vendor’s deliverables and accountable for timeliness and adequate quality of all biostatistics deliverables for the assigned compound(s).
• Contribute to thoughts and actions towards building efficient analysis and reporting processes.
• Other duties as assigned.

Requirements:

• PhD (in Statistics/Biostatistics or equivalent) with 7+ years relevant work experience.
• Oncology clinical trial experience is a plus.
• Solid experience in drug development across phases and good knowledge about health authority guidelines.
• Regulatory submission experience is a plus.
• Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts to different audience; demonstrated capacity of continued learning and application of novel statistical methodology.
• Proficiency in use of statistical software packages (e.g. SAS, R).
• Demonstrated effectiveness working on cross-functional teams to achieve team objectives.
• Excellent project management and matrix leadership skills.
• Strong communication skills with the ability to create effective collaborations within Biometrics as well as with non-statistical functions.

The Company:

G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and delivery of innovative therapies that improve the lives of those affected by cancer. This includes the Company’s first commercially available product COSELA™ (trilaciclib), a first-in-class proactive multilineage myeloprotection therapy approved by the U.S. Food and Drug Administration to help protect against chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer being treated with chemotherapy. COSELA is also being evaluated in other solid tumors, including colorectal, breast, bladder and non-small cell lung cancers.

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