Company

Gritstone bioSee more

addressAddressEmeryville, CA
type Form of workFull-Time
CategorySales/marketing

Job description

Gritstone bio is a public, next-generation personalized cancer and infectious immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The company’s goal is to identify and deploy neoantigens for novel treatments of cancer and infectious diseases. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients.
Position Summary 
The Senior Manager, Biostatistics position is to provide the statistical expertise and manage the activities for cancer vaccine studies. This individual is responsible for providing guidance to statistical issues in study design and conducting studies, regulatory interactions, or external development partners and oversight the biometrics function at CROs.  The successful candidate will be responsible and accountable for:
Responsibilities
  • 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
Minimum Education/Experience
  • Requires PhD in statistics or related fields
  • At least 3+ years of relevant experience in clinical trials and drug development are required for Senior Manager
  • 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.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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 Senior Manager, Biostatistics level position could range between $148,500 - $193,500. 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.
Refer code: 7814256. Gritstone bio - The previous day - 2024-01-16 00:38

Gritstone bio

Emeryville, CA
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