$250K — $500K+*
Who We Are
We are a dedicated team of professionals who take our work very seriously, but not ourselves too seriously. We are driven to deliver new medicines to cancer patients who desperately need solutions. We are a collection of individuals with diverse backgrounds and personalities, yet all united by this purpose to ignite the precision medicine revolution by delivering targeted therapies for those battling cancers. We are motivated by a profound sense of urgency and passion to create medicines with life-saving potential. If you enjoy co-elevating your colleagues and want to be part of a team of like-minded individuals united by a relentless pursuit to end cancer, then Kinnate may be the home for you.
Your impact at Kinnate
As the Senior Director, Biostatistics you will be our first recruit in our Biostatistics group. This role can be based in either San Francisco or San Diego.
You will function as a critical member of our cross-functional teams contributing to the design & execution of clinical studies within Kinnate’s clinical programs.
You will be responsible for creating and implementing the strategic direction for biostatistics and programming activities across all projects, in all phases of development and ensuring that robust statistical analyses and interpretations are carried out.
This is a critical ‘hands-on’ role that will lead the Biostatistics capabilities at Kinnate – and includes opportunities for both strategic leadership and the execution & oversight of critical statistics deliverables.
Your Key Areas of Responsibility:
Your future responsibilities will include:
· Developing functional Biostatistics infrastructure and capabilities
· Setting or significantly influencing the long-term strategic direction for Biometrics in alignment with the broader Development strategy
· Hiring, developing, and mentoring junior statisticians to help grow the organization
· Driving the development and implementation of innovative strategies and technologies for biostatistics
· Displaying thought leadership in novel methodologies such as Bayesian methodologies, adaptive design; simulation and statistical modeling, and/or combined phase 1/2 or phase 2/3 designs
· Directing the statistical design, conduct, and analysis of clinical trials in all phases
· Reviewing protocols and case report forms for soundness of trial design
· Reviewing and or authoring statistical analysis plans for all phases of a trial
· Delivering high quality clinical & translational data by closely collaborating with other clinical development functions (including clinical development, clinical operations, translational medicine, clinical safety, regulatory).
· Performing and/or reviewing the analysis and interpretation of clinical study results, and collaborating with clinical team to produce interim reports, final reports & publications
· Directing the development, validation and summary of integrated safety and efficacy summary documents for Regulatory and Health Authority submissions
· Evaluating and managing contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets
· Ensuring high quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices
· Develop and implement department standards and practices to ensure statistical integrity of project deliverables
New oncology therapy breakthroughs await your creative spirit and “roll-up your sleeves” approach because #patients are waiting.
The Right Stuff
· You have an advanced degree (Masters or Doctoral degree in Statistics/Biostatistics or other subject with high statistical content)
· You have at least ten, preferably 15 years, post-graduate statistical experience in the pharmaceutical industry or medical research organizations with a deep knowledge of statistical methodology and applications within drug development, especially in the oncology therapeutic area.
· You have been a Statistical leader for successful regulatory submissions & participated in global regulatory interactions
· You have demonstrated highly effective communication & presentation skills including statistical strategy
- You have prior people management experience and enjoy mentoring talented staff and building highly effective teams
· You are recognized as a leader and have a track record of building strong collaborative partnership with diverse cross-functional team members & external partners
· You are passionately committed to bring innovative oncology drugs to patients to drive better clinical outcomes.
Valid through: 1/21/2022