Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 15 days ago

Senior Manager, Clinical & Statistical Programming

Umoja Biopharma11 open roles

Pay
$170,000 – $210,000 a year
Where
Remote; Seattle, Washington, United States
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSenior Manager, Clinical & Statistical ProgrammingUmoja Biopharma · Remote; Seattle, Washington, United States

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Umoja Biopharma's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

11.8% of postings close within 7 days. Measured by our own scanner across the market. Umoja Biopharma postings stay open a median of 38 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.8%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: posted 15 days ago

Umoja Biopharma median: 38 days open

The posting

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

POSITION SUMMARY:

The Senior Manager, Clinical & Statistical Programming will be responsible for planning, executing and quality checking of data programming and statistical analysis deliverables to support clinical trial conduction and prepare submission readiness package. This role provides technical and operational leadership to ensure compliant, high-quality analysis datasets, tables, listings, and figures (TLFs) in accordance with CDISC standards and FDA guidance. This role will operate as an individual contributor; contribute significantly in building statistical programming infrastructure of the Biometric department; and may have the opportunity to lead contractors/CROs/Collaborators in preparing highly efficient, meta data driven, regulatory standards compliant clinical and statistical programming for pipeline trials.

This role will partner closely with Biostatistics, Clinical Data Management, Clinical Operations, Medical Team, and Regulatory Affairs to support submission readiness and successful regulatory interactions.

This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote within the US for the right candidate.

CORE ACCOUNTABILITIES: Specific responsibilities include:

  • Perform clinical and statistical programming activities for clinical trials and ensure the timely delivery of high-quality outputs throughout the full study life cycle.
  • Review clinical trial protocols, SAP, CRF designs, and EDC deployments, and provide input for EDC edit checks to enhance clinical trial data quality.
  • Guide and review outputs from CROs, which may encompass submission datasets, programs, and outputs to ensure the submission package (SDTM and ADaM specifications, SDTM and ADaM programs and datasets, Tables, Listings, and Figures (TLFs) outputs, define.xml, and reviewer guides, etc.) adheres to regulatory requirements and is compliant with CDISC standards.
  • Execute and support clinical and statistical programming activities for regulatory submissions including INDs, NDAs, and/or BLAs.
  • Review data management plans, data transfer plans, and test EDC deployment to ensure readiness for downstream programming.
  • Provide hands-on SAS programming support for key safety and efficacy analyses of clinical trials, as well as ad hoc exploratory and publication analyses as required.
  • Provide technical oversight to statistical and data programmers and contractors as necessary.
  • Collaborate closely with biostatisticians, study physicians, data management, clinical operations, and safety review teams to review data or programming issues and improve the overall quality of clinical trial data.
  • Support internal and external audits, inspections, and regulatory inquiries related to statistical programming deliverables.
  • Assist the department head in building the infrastructure of the biometrics department, which may include creating macros and programs, TLF shells, departmental SOPs, and best practices for clinical and statistical programming and data traceability.

The successful candidate will have:

  • BS in biostatistics, statistics, computer science, or a closely related field, coupled with extensive quantitative analysis methodologies and clinical programming proficiency with a minimum of 8+ years of experience in pharmaceutical companies or CROs is required.
  • Demonstrated leadership experience in managing projects and guiding cross functional teams.
  • A solid comprehension of statistical programming principles, advanced SAS programming expertise, extensive experience in the preparation of regulatory submission packages, and substantial knowledge of CDISC standards.
  • Exceptional attention to detail and a strong risk-mitigation mindset, a self-driven learner to continuous learning and updating programming skills and therapeutic area (TA) knowledge.
  • Excellent verbal, written, and interpersonal communication skills are mandatory for clear and efficient communication and collaboration with cross-functional teams, which may include clinical operations, data management, study physicians, statisticians, and medical writers.
  • A sound working knowledge of ICH, FDA, and GCP regulations and guidelines.

Preferred Qualifications:

  • Master's degree preferred
  • Prior experience with NDA/ BLA submission and interaction with regulatory agencies is highly desirable, as is leading early and late-phase clinical trials
  • Experience in immunology, hematology, or oncology clinical trials is preferre
  • Experience with using R in clinical analysis

Physical Requirements:

  • Ability to sit for prolonged periods of time
  • Ability to read, interpret, and review detailed technical documents, datasets, tables, listings, figures, and on‑screen material
  • This role will ideally be based out of our Seattle, WA office and will be onsite 2 days/week
  • If this role is remote, the ability to travel up to 10% as needed

Salary Range: $170,000 - $210,000

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Umoja Biopharma's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Umoja Biopharma's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Umoja Biopharma's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.