- Serve as the statistical leader for Oncology studies including an on-going Phase 2/3 study. This position plays a key role in the development of design, execution, and reporting of Gritstone’s clinical trials.
- Apply innovative study designs and statistical methodologies for clinical studies as appropriate
- Collaborate with clinical development teams as the lead statistician and oversight statisticians, SAS programmers, data management at CROs ensuring high quality deliverables in alignment with established timelines
- Provide statistical expertise in designing clinical trials, sample sizes estimation, statistical analysis plans (SAP), clinical study reports (CSR) and regulatory submissions.
- Perform statistical analysis, analysis QC, ad-hoc analysis required for clinical studies, regulatory submissions activities including manuscripts and other publications.
- Contribute to SOPs related to biostatistics practices
- Requires PhD in statistics or related fields
- At least 7+ years of relevant experience in clinical trials and drug development are required for Associate Director level.
- In-depth knowledge of statistical methods, especially Bayesian statistics, for clinical trials and be able to practice and implement them.
- Proficiency in R and major statistical software packages (e.g., SAS).
- Experience in Adaptive study designs is preferred but not required
- Oncology experience is preferred
- Experience supporting NDAs, MAAs and other regulatory interactions is preferable but not required.
- Able to work effectively and collaboratively in a fast-paced, agile company environment.
- Must be self-motivated, highly organized, detail-oriented and able to multi-task while delivering high quality work.
- Excellent interpersonal skills, including the ability to influence and to work effectively cross-functionally.
- Strategic agility, strong critical and logical thinking with ability to analyze problems.
- Strong ability to prioritize and work in an evolving environment.
- Excellent presentation and written/verbal communication skills.
- Excellent computer proficiency (MS Word, Excel, PowerPoint).
- Demonstrated strong interpersonal and communication skills.
The well-being and safety of our employees is our top priority. Gritstone requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (fully remote or site-based). Fully vaccinated is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Gritstone bio anticipates that the annual base salary for the Associate Director, Biostatistics level could range between $165,000 - $215,000. Compensation will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal position salary ranges, and market data. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Gritstone is a multistate employer and the salary offered will be market competitive. At Gritstone, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.
Gritstone’s benefit package includes medical, dental, vision, life insurance, and paid parental leave. Employees are also eligible to enroll in the 401k plan, which includes a 4% company match with immediate vesting. Employees are eligible to enroll in benefits effective the first day of employment and the competitive Paid Time Off (PTO) begins accruing on the first day as well. The job offer also includes an equity grant and eligibility for annual refresh grants based on performance. Gritstone employees also benefit from an Employee Stock Purchase Plan (ESPP) and thirteen (13) designated paid holidays as well as two (2) personal days.
Gritstone bio is an Equal Opportunity employer, as such, recruiting is conducted in a fair and non-discriminatory manner without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.