Director, Data Standards & Statistical Programming

IDEAYA Biosciences • South San Francisco, CA

20h • $215,000 - $266,000 • Hybrid

About The Position

About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially targeted first-in-class therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be amid brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed to being at the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use teamwork to move science forward. For more information, please see www.ideayabio.com. Location: South San Francisco, CA. Position Summary: We are seeking a Director of Data Standards & Statistical Programming to join IDEAYA. The Director of Data Standards & Statistical Programming will be responsible for the delivery of CDISC compliant data sets across trials and indications from Phase I to Phase IV. This role will report to Senior Director, Data Standards & Statistical Programming and will work in collaboration with Biostatistics, Data management, Clinical Science, Pharmacovigilance and DMPK to ensure results are of high quality and data standards are aligned with regulatory expectations and industry standards. The director will also partner with IT to ensure programming infrastructure is secure, scalable and compliant in accordance with industry standards and internal processes. This position is based in our South San Francisco headquarters and required to be onsite four days per week per our company policy.

Requirements

• MS. (in mathematics, statistics, computer science or equivalent) with 12+ year statistical programming experience in Bio-Pharma industry using SAS to analyze clinical trial data.
• At least 8 years of experience using CDISC standards and minimum of 4 years in oncology clinical trials, using RECIST to derive key primary and secondary endpoints.
• Expertise in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
• Expertise in creating CDISC compliant SDTM and ADAM datasets for NDA submissions.
• Expertise in developing datasets and outputs for integrated summaries (ISE/ISS) as statistical programming lead on NDA filings in collaboration with Biostatistics Lead.
• Good knowledge of FDA Regulations, ICH, EMA, PMDA guidance documents.
• Experience implementing GXP compliant SAS infrastructure in collaboration with IT.
• Experience developing and implementing programming SOPs and Work Instructions.
• Excellent verbal and written communication skills to collaborate across functions
• Excellent project management, and problem-solving skills to lead programming.
• Ability to influence and adapt with positive attitude in fast paced organization.
• Promotes teamwork in Biometrics and across Clinical Development.
• All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct. Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels
• This position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

Nice To Haves

• At least 4 years in small or medium biotech preferred.
• Knowledge of R programming and/or python is a plus

Responsibilities

• Plan and track statistical programming activities in partnership with Biostatistics.
• Oversee the work of statistical programmers to ensure high quality accurate results.
• Develop SOPs, Work Instructions and processes for efficient execution of SAS code.
• Design, develop and validate SAS programs that create CDISC compliant datasets and results for clinical study reports, safety reporting, exploratory analyses and Publications.
• Lead creation of SAS transport files, Define.XML, Pinnacle 21 reports and Reviewer guides.
• Lead creation of CDISC compliant data set specifications across indications and programs.
• Translate complex programming requests into analysis data specifications and TLFs.
• Promote good documentation in programming, implement software and tools
• Review Data Management Plan, data transfer specifications and edit check specifications.
• Contribute to statistical analysis plans; provide additional expertise in the analysis of clinical trials as it relates to protocol development, case report form design, and data collection.
• Automate processes that enhance programming infrastructure and workflows.
• Champion processes and solutions that advance clinical trials

Benefits

• Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director