Director, Statistical Programming

Summit Therapeutics, Inc.; Palo Alto (CA); In loco; USD 203.000 - 253.000; Tempo pieno

Descrizione del lavoro

Summit Therapeutics Inc. is seeking a Director of Statistical Programming to lead the statistical programming team, develop plans for clinical trials, and oversee SAS programs for data analysis and reporting in oncology.

This role ensures adherence to ICH, regulatory standards and CDISC ADaM specifications. The successful candidate will supervise internal and vendor teams, drive standardization across programs, and contribute to NDA and sNDA submissions while coordinating with Biostatistics and

Competenze

• PhD or MS with extensive experience in statistics for clinical trials.
• Expertise in designing analyses and reporting for regulatory submissions.
• Strong knowledge of CDISC standards and ADaM data structures.

Mansioni

• Provides technical and/or operational leadership for statistical programming in clinical studies and NDA submissions.
• Collaborates with Biostatistics to implement analyses and develop ADaM specifications.
• Manages internal and vendor statistics programming resources and ensures timely, high-quality deliverables.
• Develops and maintains programming standards and documentation.

Conoscenze

SAS programming

Biostatistics

CDISC standards

Clinical trials

Regulatory submissions

Formazione

PhD in statistics

MS in biostatistics

Strumenti

SAS

R

EAST

Descrizione del lavoro

About Summit

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

About Summit

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s Team Is Inspired To Touch And Help Change Lives Through Summit’s Clinical Studies In The Field Of Oncology. Summit Has Multiple Global Phase 3 Clinical Studies, Including

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview Of Role

The Director of Statistical Programming oversees managing statistical programming projects and creating strategic plans related to clinical trials and medical affairs publications. They lead the team in developing, maintaining, validating and running SAS programs that analyze and report clinical trial data, following statistical analysis plans, ICH guidelines and regulatory requirements. They are responsible for the structure of the statistical programming function and representing the function in cross-functional activities, particularly in regard to data collection, analysis, and integration of clinical trial data and real-world evidence.

Role And Responsibilities

• Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
• Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Works closely with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs.
• Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors.
• Writes SAS programs that produce or validate tables, listings, figures, and analysis datasets, in support of clinical studies or complex integrated analyses for submission.
• Performs, plans, and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program.
• Writes specifications to describe programming needs, including development and maintenance of complex / ADaM specifications and reviewer guides.
• May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.
• Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations).
• Leads efforts to develop programming processes consistent with industry best practices.
• Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; Reviews and provides expert input to statistical analysis plans and other related documents.
• Partners with or oversees CROs or Programming vendors to perform any of the above tasks.

Experience, Education And Specialized Knowledge And Skills

• PhD with 8+ years of experience or MS with 11+ years of experience in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech industry, or healthcare experience
• Experience in supporting oncology phase II/III clinical studies
• Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA)
• In-depth knowledge of CDISC standards
• Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc.
• Excellent written and verbal communication skills
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting demands.
• Work in a fast-paced, demanding and collaborative environment

This is the pay for this position

Pay Transparency

$203,000 - $253,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [e-mail] to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.