Associate Director, Biostatistics, Oncology

3 weeks ago

Palo Alto CA, United States Ascendis Pharma Full time

Job Description Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.
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. 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.
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.
Contribute to the integration and analysis of totality of data. Derive insights across different data (such as biomarkers) by using appropriate statistical tools.
Oversee the deliverables and analyses outsourced to CROs, as needed.
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.
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.
May require occasional evening and/or weekend commitment.
Occasional domestic and international travel may be required.
Talent Acquisition Partner or Human Resources Director) is not allowed. Medical insurance
~ Dental insurance
~Disability insurance

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