Scorpion Therapeutics
Role Summary
Director Biostatistics (Oncology) oversees statistical leadership for assigned clinical trials and programs, collaborates with development partners to harmonize standards, and represents Statistics in cross-functional teams. Responsible for statistical aspects across partner-sponsored studies and IITs. Responsibilities
Provide statistical support and leadership for assigned clinical trials and programs in accordance with company objectives. Oversee and give statistical guidance on trials within a program or platform. Train and guide colleagues as an SME in topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, or RWE/epidemiology. Provide statistical input into clinical development plans, protocols, study reports, regulatory submissions, and publications ensuring accurate deliverables. Perform and/or verify sample size calculations; lead development of SAPs and TLFs; perform analyses and validate results. Participate in planning for health authority meetings and prepare associated documents and responses. Oversee outsourced statistical CRO activities and deliverables ensuring high quality and timeliness. Provide input to database requirements and collaborate with Clinical Data Manager to ensure data quality standards. Guide Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming. Serve as lead contact in Biostatistics for external partners on assigned studies. Support initiatives to develop, implement and improve standards, processes and infrastructure. Keep updated on development of new statistical methodologies and technologies. Mentor Associate Directors or less experienced Directors; may assume line management responsibilities and recruit/develop/retain talent. Qualifications
PhD or Masters in (Bio)Statistics, Mathematics or equivalent. Minimum 8 years (10 years for masters) in the pharmaceutical industry and/or CRO. At least 5 years of work/leadership experience, overseeing statistics staff and representing Biostatistics in a matrix organization and multidisciplinary teams. Experience in planning, conducting and analyzing oncology trials from phase I-IV, including scientific publications. Experience supervising outsourced activities and developing/executing outsourcing strategies. Strong knowledge of clinical development, study designs, and advanced statistical methods (adaptive design and/or Bayesian is a plus); familiarity with regulatory guidelines (ICH, FDA, EMA). Strong knowledge of statistical analysis software (SAS and/or R) and sample size software (e.g., EAST and/or NQuery). Deep understanding of topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology (a plus). Excellent analytical, communication, and interpersonal skills; ability to work in a fast-paced environment. Skills
Analytical thinking and problem solving Advanced statistical methods and study design Statistical programming (SAS, R) and sample size calculations Regulatory knowledge (ICH, FDA, EMA) Leadership and mentorship Education
PhD or Masters in (Bio)Statistics, Mathematics or equivalent
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Director Biostatistics (Oncology) oversees statistical leadership for assigned clinical trials and programs, collaborates with development partners to harmonize standards, and represents Statistics in cross-functional teams. Responsible for statistical aspects across partner-sponsored studies and IITs. Responsibilities
Provide statistical support and leadership for assigned clinical trials and programs in accordance with company objectives. Oversee and give statistical guidance on trials within a program or platform. Train and guide colleagues as an SME in topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, or RWE/epidemiology. Provide statistical input into clinical development plans, protocols, study reports, regulatory submissions, and publications ensuring accurate deliverables. Perform and/or verify sample size calculations; lead development of SAPs and TLFs; perform analyses and validate results. Participate in planning for health authority meetings and prepare associated documents and responses. Oversee outsourced statistical CRO activities and deliverables ensuring high quality and timeliness. Provide input to database requirements and collaborate with Clinical Data Manager to ensure data quality standards. Guide Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming. Serve as lead contact in Biostatistics for external partners on assigned studies. Support initiatives to develop, implement and improve standards, processes and infrastructure. Keep updated on development of new statistical methodologies and technologies. Mentor Associate Directors or less experienced Directors; may assume line management responsibilities and recruit/develop/retain talent. Qualifications
PhD or Masters in (Bio)Statistics, Mathematics or equivalent. Minimum 8 years (10 years for masters) in the pharmaceutical industry and/or CRO. At least 5 years of work/leadership experience, overseeing statistics staff and representing Biostatistics in a matrix organization and multidisciplinary teams. Experience in planning, conducting and analyzing oncology trials from phase I-IV, including scientific publications. Experience supervising outsourced activities and developing/executing outsourcing strategies. Strong knowledge of clinical development, study designs, and advanced statistical methods (adaptive design and/or Bayesian is a plus); familiarity with regulatory guidelines (ICH, FDA, EMA). Strong knowledge of statistical analysis software (SAS and/or R) and sample size software (e.g., EAST and/or NQuery). Deep understanding of topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology (a plus). Excellent analytical, communication, and interpersonal skills; ability to work in a fast-paced environment. Skills
Analytical thinking and problem solving Advanced statistical methods and study design Statistical programming (SAS, R) and sample size calculations Regulatory knowledge (ICH, FDA, EMA) Leadership and mentorship Education
PhD or Masters in (Bio)Statistics, Mathematics or equivalent
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