Senior Statistical Programmer at Olema Oncology

San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Mar, 26

Salary

180000.0

Posted On

25 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Programming, SAS Programming, Clinical Trials, Regulatory Compliance, Data Analysis, Collaboration, Communication, Problem Solving, Attention to Detail, Programming, CDISC Standards, SDTM, ADaM, Oncology Trials, Safety Data Review, Project Management

Industry

Biotechnology Research

Description

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. #LI-MK1 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. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.

Responsibilities

The Senior Statistical Programmer will be accountable for all assigned statistical programming deliverables, ensuring adherence to company SOPs and regulatory standards. Responsibilities include validating CRO deliverables, programming statistical outputs, and collaborating with study teams.