Associate Director, Statistical Programming
Salary: $175,000/yr- $210,000/yr, + 25% Target Bonus + Substantial Equity
Fully Remote (candidates must be based in the PST Time Zone)
Our client is a cutting edge Oncology company with a truly robust pipeline aimed at developing novel therapies that treat Cancer. This company has two innovative platforms that collectively have 9 different indications in various phases of development. What is particularly exciting about this company is that not only will you get to contribute to some early phase studies. They also have 3 indications in Phase 3 of development showing a high promise of entering commercialization in 2024. If you are looking for an opportunity to gain exposure to multiple phases of development and join a company right before a massive inflection point don't hesitate to apply.
The Associate Director will be responsible for:
- Provide management and oversight of statistical programming resources including FTEs, contractors and CROs (e.g., SDTM vendors, independent statistical analysis center for DMCs)
- Provide timeline and resource forecasts for statistical programming deliverables.
- Ensure quality and timely delivery of analysis for our clinical trials.
- Collaborating with internal team members effectively to help develop/enhance/maintain global macros and processes.
- Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, academic community, and healthcare providers) via QC of documents with clinical data.
- Ensure that the interpretation of data obtained from our clinical trials is accurate and the process conforms to the SOPs and Work Practice guidelines.
- Oversee Programming support for relevant deliverables, such as Investigator Brochures, publications, US, and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation (Define.xml), Reviewer's Guide (SDRG, ADRG), TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), CRF reviews.
- Hands-on programming of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.
- Verification and review of documents, spreadsheets, slides for in-house presentations and external publications.
The Associate Director should have the following qualifications:
- MS, BS/BA degree or other suitable qualification with relevance to the field.
- Hands-on experience in programming for early-stage clinical trials.
- A demonstrable record of strong leadership and teamwork.
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.
- Effective, Customer Focused, Responsive, Accountable, and possesses excellent written and verbal communication skills.
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute is extremely important.
- Industry experience is essential.
Benefits:
- Stipend for gas
- Half days Fridays
- Breakfast/Lunch stipend
- Medical Benefits fully covered by the company
- 5 weeks PTO
