Principal Programmer, Statistical Programming

Job Description

Job Description

About BlossomHill Therapeutics:

BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors.

For more information visit BlossomHill Therapeutics .

Position Summary:

The Principal Programmer, Statistical Programming, will be responsible for leading programming activities for multiple studies to support clinical development, medical affairs, drug safety, CSR and submission; contribute to standard, process development and programming team growth. This is an onsite position based in San Diego.

Key Responsibilities:

• Provide technical and project management leadership in creating software programs designed to analyze and report oncology trials.
• Serve as programming lead for clinical studies to manage and lead programming activities.
• Write programs to perform ad hoc analysis to support clinical development, medical affairs, and drug safety.
• Create/review programming plan, specifications for datasets and TLFs. Expert level of understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models.
• Develop and validate SAS® programs to produce high quality deliverables for in-house and outsourced projects in compliance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures.
• Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions to identified issues; ensure datasets are in compliance with submission standards.
• Create/oversee the creation of proper documentation related to statistical programs, datasets, review guides and QC documentation, ensure documentations are in compliance with SOPs and/or meeting submission requirements.
• Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs.
• Ensure that statistical programming deliverables are in compliance with regulatory requirements, industry and company standards.
• Develop global macro tools that can improve overall efficiency and capacity of programming function.
• Contribute to the development, implementation and continuous improvement of standards, SOPs and work instructions to guide department standard practice.
• Effectively communicate in a project team environment, within department, among functional groups and external collaborators.
• Perform other programming duties as assigned.

Qualifications:

Required

• Minimum of BS required in Statistics, Computer Science, Life Sciences or other related fields.
• BS with 7+ years or MS with 5+ years of SAS programming experience in drug development in CRO or pharma/biotech company.
• Experience with data reporting tools in a clinical trial setting.
• Expert level of SAS programming skills; knowledge of some additional programming languages (e.g. R, Python, PL/SQL) a plus.
• Good knowledge regarding clinical trial design, data collection/cleaning, regulatory requirements and their relationship with data analysis.
• Familiar with ICH guidelines, possess advanced knowledge of submission requirements and standards.
• Advanced knowledge of CDISC standards, including CDASH, SDTM and ADaM.
• Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests.
• Excellent verbal and written communication skills.

Preferred

• Minimum 2 years of experience in developing software in a clinical trial environment using SQL, SAS or R. Relevant industry internship experience may be counted.

Salary Range:

The base salary range for this position is $154,155 to $195,000 When determining the final offer, we consider multiple factors including, but not limited to, relevant education, skills, and years of experience, internal pay equity, geographic location, and market data.

Equal Employment Opportunity:

The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Recruiters and Agencies:

BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHill employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

E-Verify:

BlossomHill Therapeutics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) to resolve the issue.