- Research, identify and implement statistical strategies for clinical programs, regulatory submissions, and regulatory interactions. Participate in regulatory interactions and provide biostatistics input.
- Serve as statistician on protocol design, endpoint selection and sample size calculation, case report form (CRF) design, statistical analysis plan (SAP), through clinical study report (CSR). Author documents or sections of documents as needed to ensure scientific rigor and internal consistency.
- Collaborate with the project team on trial execution.
- Support the need of ongoing data review by the cross-functional team and effectively communicate results and message to the project team, management team, and/or other stakeholders.
- Generate data summary and visualization to support internal decision-making.
- Ensure timely delivery of planned or ad hoc data analysis with high quality.
- Support statistical activities on IB, DSUR, publications, conference presentations, etc.
- Provide statistical and analytical support for Research, Translational Research, and CMC as needed. Contribute to the integration and analysis of totality of data. Derive insights across different data (such as biomarkers) by using appropriate statistical tools.
- Research and apply statistical modeling and simulation approaches as needed.
- Keep abreast of the evolving innovative statistical approaches, design considerations, and development in the relevant therapeutic areas.
- Effectively communicate complex statistical topics in a professional manner to statistical and nonstatistical audiences.
- Oversee the deliverables and analyses outsourced to CROs, as needed.
- Ph.D. or equivalent degree in statistics/biostatistics or related discipline with 5+ years, or Master's degree with 8+ years in the biotech, pharmaceutical or CRO setting.
- Proficiency in experimental design, statistical analysis methodologies, and related regulatory guidelines applicable to Clinical Research.
- Sound knowledge of theoretical and applied statistics.
- Strong analytical and problem-solving skills in identifying needs/risks and formulating solutions independently and proactively.
- Experience in oncology/hematology drug development is preferred.
- Proficient programming skills in SAS and R.
- Experience in managing and collaborating with CROs.
- Must have excellent people skills and ability to work successfully in a team environment.
- Excellent verbal and written communication and presentation skills.
- May require occasional evening and/or weekend commitment.
- Occasional domestic and international travel may be required.
- Salary range: $190-215K/year
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
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Associate Director, Biostatistics, Oncology - Palo Alto, United States - Ascendis Pharma
Description
Job Description
Job DescriptionHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.
We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills.
We promote a trusting and appreciative company culture and value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.
Position Summary
The Associate Director of Biostatistics will provide statistical leadership, oversight, expertise and technical support of the clinical development activities. This position will provide statistical support to innovative study designs that are suitable for Ascendis' oncology clinical programs. This individual will collaborate closely with the cross-functional teams on protocol development, study execution, be responsible for data analysis and interpretation of results, and work closely with Data Management and Statistical Programming resources to achieve all Biometric deliverables and activities at CROs. Additional analysis support of non-clinical / biomarker /CMC data and derive insight to contribute to Ascendis' scientific research may be requested. The role reports to Head of Biometrics, Oncology.
Key Responsibilities
Requirements
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Benefits
Associate Director, Biostatistics, Oncology professionals in Palo Alto
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Aussama Khalaf Nassar
Academic Surgeon Educator