G1 Therapeutics
  • Durham, NC, USA
  • Full Time

Primary Job Responsibilities:

The Associate Director will serve as a compound lead statistician for one or more oncology compounds in clinical development and is responsible and accountable for all statistical aspects for the assigned compound's development throughout development phases and regulatory filing activities. This role will provide strategic input in collaboration with other functions in identifying an efficient path to advance pipeline compound(s). The successful candidate is 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.

  • 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.

Job and Level Requirements:

  • PhD (in Statistics/Biostatistics or equivalent) with 7+ years relevant work experience or MS (in Statistics/Biostatistics or equivalent) with 10 + 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.

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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