- Serve as a lead statistician for one or more drug programs and manage statistical efforts for multiple clinical studies
- Represent the biometrics functions on cross-functional and program teams and make strategic contributions to the clinical development plan (CDP)
- Drives data-driven decision-making in a multidisciplinary team environment by providing a high level of statistical rigor to the analyses and interpretation of complex data generated.
- Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, and cross-study analyses including statistical methodology, interpretations, regulatory submissions, and follow-up.
- Serve as the biostatistical lead in regulatory submissions and inspections
- Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
- Author/review statistical analysis plans for studies, ISS/ISEs, and author/edit shells for tables, figures, and listings
- Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
- Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
- Work with statistical programmers or CROs to generate tables, figures, and listings
- Perform ad hoc and exploratory statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
- Support the preparation of publications, including manuscripts, posters, and oral presentations
- Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
- May manage FTE/contractor direct report(s) as needed
- PhD in biostatistics, statistics, or a related field with at least 8 years of relevant clinical trial experience or MS in statistics or equivalent with at least 10 years of relevant clinical trial experience
- Knowledge of statistical methods for clinical trials
- In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
- Experience with NDAs/BLAs, MAAs and other regulatory submissions
- Proficient in statistical programming (SAS or R is required)
- Experience with trial design software (e.g., EAST or nQuery)
- Good communication skills and ability to work with cross-functional study teams
- Good influencing skills to ensure good statistical and quantitative expertise is adopted in clinical development
- Good organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
- Positive and collaborative attitude
- Patients - We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.
- Accountability - We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
- Transparency - We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
- Honesty and Integrity - Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
- Stewardship - We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
- Lead from where you are - regardless of role or level, we motivate each other to achieve common goals.
- Drive business results - we navigate forward with our eye on the highest priorities.
- Partner and collaborate - we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
- Continuously evolve and improve - we try, we learn, we revise and try again.
- Non-accrual paid time off
- Summer vacation bonus
- Global, company-wide summer and winter shutdowns
- An annual lifestyle allowance
- Monthly cell phone stipend
- Internal rewards and recognition program
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan with company match
- Life and Supplemental life insurance for family
- Short and Long Term Disability insurance
- ESPP offering
- Health savings account with company contribution
- Flexible spending account for either health care and/or dependent care.
- Family planning benefit
- Generous parental leave
- [if applicable] Car allowance
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Director, Biostatistics - Watertown, United States - Deciphera Pharmaceuticals
Description
Company DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera's switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.
See here for more details on our portfolio.
Job Description
We are seeking a Director of Biostatistics to join our team. In this role, the successful candidate will serve as the lead study statistician on one or more drug programs, which may include complex and/or pivotal studies. The successful candidate may also lead regulatory submission related tasks and represent Deciphera in communications with regulatory authorities.
This is an exciting opportunity to join a fast-paced oncology-focused biopharmaceutical company making a difference for patients globally. You will join a group of highly motivated, top-notch biostatistics and clinical development professionals and will be a key player in shaping the biostatistical strategy for key clinical studies. The role offers exciting opportunities for learning and growth as you partner cross-functionally to develop statistical analysis plans and contribute to the overall clinical development strategy.
This position will report to the Senior Director, Biostatistics and work on-site at our Waltham, MA office. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office. Deciphera expects a minimum number of in-office days. Specific days spent in the office should be determined in conjunction with your manager.
What You'll Do:
We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.
We offer an outstanding culture and opportunity for personal and professional growth based on our "PATHS" Core Values:
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.
