Principal Statistical Programmer

Boston, MA, United States

Who We Are >>> Why You Should Work With Us

Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.

Onto something big, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.

Our  modern hybrid workplace model  encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.

While at the lab/office, our teams  build their   camaraderie , opening the door for more authentic mentorship and career development opportunities. While at home, employees can  make the most of their time  – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees  the best of both work models .

As the Principal Statistical Programmer reporting to the Senior Director of Statistical Programming, you will be accountable for all statistical programming deliverables in adherence to company SOPs and ICH/GCP. You will also help to create and implement Statistical Programming policies and procedures.

This role is based out of our San Francisco, CA office.

Your work will primarily encompass:

Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget

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

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

Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc.

Ensure timely delivery of all statistical deliverables for each study assigned

Collaborate with study statistician and study team members to come up with 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

Knowledge:

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

Strong SAS programming and graphic programming skills

Able to guide the successful completion of major programs and projects

Strong analytical and communication skills

Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies

Broad knowledge of medical/biological terminology in relevant therapeutic areas

Experience:

12 years of related experience with a Bachelor’s degree in Statistics; or 8 years and a Master’s degree; or a PhD with 5 years experience

Experience of leading 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

Experience in management of CROs with respect to statistical programming

Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization

Attributes:

Leadership skills in proactively prioritizing tasks, flexible to changes, conflict resolution, and effective partnership

Strong verbal and written communication skills

Effectively represent statistical programming in multidisciplinary meetings

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

Have impeccable professional ethics, integrity and judgement

COMP RANGE TEXT:

The base pay range for this position is expected to be  $189,000 to $201,000 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.

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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.

Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Additional Note/Fraud Alert :  Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema .