Associate Director, Biostatistics
Inflammatix
This job is no longer accepting applications
See open jobs at Inflammatix.See open jobs similar to "Associate Director, Biostatistics" Khosla Ventures.We are seeking an experienced Associate Director, Biostatistics to supervise and support the biostatistical strategy, study design and statistical analysis for Inflammatix' registrational and non-registrational clinical trials. This role will be a critical part of the Clinical Operations and Data Management leadership team in support of clinical trials and, data analysis. The candidate will represent and lead the Biostatistics function and serve as the lead person participating in multidisciplinary project team meetings, collaborating with other team members, and incorporating knowledge of cross-functional areas to advise and provide sound statistical guidance to teams. 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 also be provided for our clinical, product development, clinical laboratory, bioinformatics and machine learning teams. Development of standards, technical quality and standardized process in the biostatistics function will also be driven by the candidate. This role will not be boring! Biostatistics is an essential part of the Clinical Affairs team composed of highly experienced, motivated and agile staff. The candidate will report into the Head of Clinical Operations with a dotted line into the Chief Medical Officer. Success will lead to numerous publications, successful FDA interactions, and career growth opportunities as a leader in this important function.
PRIMARY RESPONSIBILITIES:
- Manage, oversee and mentor the biostatistics team and indirectly manage cross functional or matrix teams as appropriate
- Participate in the design of clinical trials and case report forms, and provide sample size calculations and statistical methodology for study protocols
- Act as the core team member/lead biostatistician for all clinical trials
- Author statistical analysis plans as well as tables and figures listings
- Provide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teams
- Lead statistical analysis of data obtained in numerous registrational clinical trials
- Analyze and visualize data generated in a wide variety of Inflammatix-sponsored and investigator-initiated studies
- Collaborate with Clinical Affairs team members (Clinical Operations, Data Management, Clinical Programming, Clinical Science, Medical Affairs) on statistical issues
- Support Clinical Affairs teams in pre-submission discussions, preparation of clinical study reports for submission to regulatory agencies, ie FDA, and in responses to queries from regulatory agencies
- Provide statistical support for clinical laboratory, product development, machine learning and bioinformatics activities
- Co-author publications
- Perform case report form review, edit-checks and assist in database clean-up
- Collaborate with Product Development, 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)
QUALIFICATIONS:
- MS degree in statistics or biostatistics or related field; PhD preferred
- 5+ years IVD-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 written, oral and face to face interactions and submissions to regulatory agencies, ie FDA
- 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
- Good data visualization skills
- Excited to ‘wear many hats’, and self-motivated to take on new challenges
- Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all direct reports, including hiring and onboarding new team members
- 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
- The base salary range for this position is $165,000 - $220,000 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.
This job is no longer accepting applications
See open jobs at Inflammatix.See open jobs similar to "Associate Director, Biostatistics" Khosla Ventures.