Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.
You can view our latest corporate deck and other presentations here.
About the Role >>> Senior Statistical Programmer
As the Senior Statistical Programmer reporting to the Principal Statistical Programmer, you will be accountable for all assigned statistical programming deliverables in adherence to company SOPs and ICH/GCP. This is a great opportunity to work on late phase trials and be a part of a team helping patients with breast cancer.
This role is based out of our San Francisco office and will require about 10% travel.
Your work will primarily encompass:
Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences
Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, Safety Detection, etc.
Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer’s guide, annotated CRFs) conforms to SOPs and to regulatory specifications
Ensure timely delivery of all statistical deliverables for each study assigned
Collaborate with study team members to negotiate timelines for statistical programming deliverables and other related action items
Follow departmental SOPs and processes for operational excellence
Lead statistical programming activities for regulatory submissions following CDISC standards
Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan
Take ownership for the completion of SDTM and ADAM specifications for assigned studies
Ideal Candidate Profile >>>
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge
Bachelor’s degree is required; advanced degree (MS, PharmD, PhD) preferred
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Thorough knowledge of SDTM/ADaM specifications and programming
Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies
Broad knowledge of medical/biological terminology in relevant therapeutic areas
Strong SAS programming and graphic programming skills
Experience
Minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience;
Experience of working both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings
Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses
Experience with oncology trials is preferred
Experience with R is a plus
Experience with SAS Graphics is a plus
Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus
Attributes
Strong ability to produce in-house ADaM datasets and TFLs for CSR and for other key deliverables is a must
Able to guide the successful completion of major programs and projects
Strong analytical skills
Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization
Skills in proactively prioritizing tasks, flexible to changes, conflict resolution, and effective partnership
Strong verbal and written communication skills
Commitment to excellence
Self-motivated and enthusiastic, fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
Impeccable professional ethics, integrity and judgement
The base pay range for this position is expected to be $160,000 - $180,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
Important Information >>>
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
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