We are seeking an experienced Biostatistician to help with clinical study design, data analysis and medical writing. The candidate will perform power analyses, assist in clinical trial design in support of FDA clearance and evidence generation for the Inflammatix product portfolio. Cross-departmental statistical support will be provided for our clinical, development, laboratory and (bio)informatics teams. This role will not be boring! Biostatistics is an essential part of the Clinical Affairs team composed of highly experienced, motivated and agile staff. Success will lead to numerous publications, successful FDA interactions, and career growth opportunities. On-the-job learning and a desire to say ‘yes’ to new things are expected.
- Participate in the design of clinical trials and case report forms, and provide sample size calculations and statistical methodology for study protocols
- Author statistical analysis plans, tables, figures and listings
- Collaborate with Clinical Affairs team members (Clinical Operations and Data Management, Clinical Science, Medical Affairs) on statistical issues ranging from Pre-IDE discussions, preparation of submissions to regulatory agencies to statistical support in response to queries from regulatory agencies
- Write statistical reports for regulatory submissions
- Provide statistical support for clinical laboratory and product development activities
- Analyze and visualize data generated in a wide variety of Inflammatix-sponsored and investigator-initiated studies
- Co-author publications
- Perform case report form review, edit-checks and assist in database clean-up
- Collaborate with Computational Biology and Machine Learning teams on statistical topics
- Collaborate with statisticians and principal investigators on statistical analyses for investigator-initiated studies
- Contribute to development of departmental standards (e.g., CRF design, ADaM datasets, TFL Mocks)
- MS degree in statistics or biostatistics or related field; PhD preferred
- 5+ years industry experience
- Broad experience in planning, analyzing and reporting clinical studies
- Strong statistical background and knowledge including parametric and non-parametric statistics, categorical data analysis, and longitudinal data analysis
- Proficient in SAS and R
- Experience in designing and analyzing in vitro diagnostics (IVD) studies (preferred)
- History of co-authorship for manuscript/abstracts (preferred)
- Background in Bayesian statistics (preferred)
KNOWLEDGE, SKILLS & ABILITIES
- Excellent verbal and written communication
- Experience in written, oral and face to face interactions and submissions to regulatory agencies
- Good data visualization skills
- Excited to ‘wear many hats’, and self-motivated to take on new challenges
- Track record of success in a deadline-driven and multi-task environment
- Well organized and detailed oriented
- Ability to work in diverse team settings
- Knowledge of CDISC (preferred)
- Knowledge in infectious diseases, emergency or ICU medicine (preferred)
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time, exempt
- Benefits: Medical, dental, and vision; 401(k), generous leave and more
- Location: Remote or Hybrid/Sunnyvale, CA
- The base salary range for this position is $142,000 - $186,000 per year which represents the low and high end of the anticipated salary range for this exempt position.
- Please note that actual offer will vary based on factors including, but not limited to the candidate’s geographic location, job-related knowledge, skills, and experience among other factors including internal equity. As such, there is the possibility that the final, agreed-upon base salary may be outside of the lower or upper end of the range. Please also note the compensation range listed is just one component of the company’s total rewards package. A bonus and/or long term incentive units may be provided as part of the total compensation package, in addition to the full range of medical, financial and/or other benefits, dependent on the level and position offered.
- U.S. employees are offered medical, dental and vision insurance, as well as access to HSA, FSA, commuter, LTD, STD and basic life insurance. Employees are eligible to enroll in our company 401k plan and employer match. Employees accrue up to 15 paid vacation days, 7 paid sick days and 10 paid holidays per calendar year. Inflammatix U.S. offices are closed for winter break each year between Christmas and New Years Day and the company offers this time as additional paid time off for U.S. salaried/exempt employees.
Inflammatix requires all employees to be vaccinated against COVID-19 (subject to any legally protected exemptions). For travel, Inflammatix requires compliance with all applicable local and national health and safety guidelines.
Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.
Notice to Agencies: Our internal Talent Acquisition Team manages all career opportunities. Agencies and independent recruiters must be approved as a vendor by the Legal and Talent Acquisition teams at Inflammatix before submitting candidates (for any current or future positions) to any employee of Inflammatix. We do not accept unsolicited resumes or profiles from agencies or independent recruiters under any circumstances. Inflammatix will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume or profile. Please do not contact Inflammatix employees directly. Compliance with this request will impact our decision to engage or work with you or your agency and/or representatives in the future.