GRABS
Rio Claro
BRL 200.000 - 250.000
Descrição da oferta de emprego

Director, Biostatistics

Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead guided by our core values, we'll meet these challenges. Join us!

Duties and responsibilities:

  1. Key contributor to the statistical strategy for clinical studies within therapeutic area of focus
  2. Provide support to the clinical development team and other functional groups to enable robust study designs and execution of the statistical methodology
  3. Contribute to clinical protocol and clinical study report development, including authorship of the statistical sections of the protocols and clinical study reports
  4. Presents statistical results internally and works with other functional groups on the interpretation of the statistical results
  5. Author statistical analysis plans and shell tables, figures, and listings
  6. Review eCRF designs, eCOA specifications, and IRT specifications to ensure data collection tools meet requirements of the study and statistical analysis plan
  7. Work with statistical programming team to execute statistical analysis plan and review tables, figures, and listings
  8. Support regulatory submissions, including INDs, DSURs, BLAs/NDAs, briefing books, and post-submission activities
  9. Support preparation of publications, including manuscripts, posters, and abstracts
  10. Works with department head to develop and implement processes and best practices
  11. Manage and/or mentor junior level statisticians or contract statisticians

Qualifications

  • PhD (9+ years of relevant experience) or MS (12+ years of relevant experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry, or healthcare experience
  • Strong knowledge of statistical methodology, clinical trial designs, and statistical computing/programming software (e.g., SAS and/or R)
  • Experience in global clinical trials and regulatory submissions and interactions
  • Understanding of data standards including SDTM and ADaM
  • Excellent interpersonal, communication, writing, and organizational skills
  • Team-oriented individual with a focus to thrive on cross-functional efforts

At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Director level position, with a compensation range of $210,000 - $240,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).

Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.

Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpines culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.

Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.

Exciting challenges lie aheadguided by our core values, well meet these challenges. Join us!

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