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Remote Director Statistical Programming Jobs in Fremont, CA

Reports to: Director, Clinical Statistics & Data Management Location: Remote Primary ... Proficiency within statistical programming using R and/or SAS required; experience with Python and ...

Reports to: Director, Clinical Statistics & Data Management Location: Remote Primary ... Proficiency within statistical programming using R and/or SAS required; experience with Python and ...

Engineering Director

San Jose, CA · Remote

$167K - $208K/yr

Value Stream Manager - Machining or Sheet Metal Full-time / Permanent Remote / With travel across ... The Director of Engineering is a senior leadership role responsible for developing and aligning a ...

Engineering Director

San Jose, CA · Remote

$167K - $208K/yr

Value Stream Manager - Machining or Sheet Metal Full-time / Permanent Remote / With travel across ... The Director of Engineering is a senior leadership role responsible for developing and aligning a ...

Engineering Director

San Jose, CA · Remote

$167K - $208K/yr

Value Stream Manager - Machining or Sheet Metal Full-time / Permanent Remote / With travel across ... The Director of Engineering is a senior leadership role responsible for developing and aligning a ...

Tennis Data Scientist

San Francisco, CA · On-site +1

$135K - $190K/yr

... is remote from the USA. Duties: * Ideate, develop and improve machine learning and statistical ... directing development efforts. * Adhere to software engineering best practices and contribute to ...

... is remote from the USA. Duties: * Ideate, develop and improve machine learning and statistical ... directing development efforts. * Adhere to software engineering best practices and contribute to ...

... is remote from the USA. Duties: * Ideate, develop and improve machine learning and statistical ... directing development efforts. * Adhere to software engineering best practices and contribute to ...

Data Scientist

San Francisco, CA · On-site +1

$150K/yr

We believe that oddsmaking is a challenge rooted in engineering, mathematics, and sports betting ... This position is remote from the USA or Canada. Duties: * Develop infrastructure for trader ...

Director of Engineering Remote [within the US] ABOUT THE ROLE: The Engineering Director is responsible for leading large-scale engineering initiatives across multiple teams, ensuring that the ...

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Remote Director Statistical Programming information

See Fremont, CA salary details

$168K

$306.7K

$376.6K

How much do remote director statistical programming jobs pay per year?

As of Aug 24, 2026, the average yearly pay for remote director statistical programming in Fremont, CA is $306,668.00, according to ZipRecruiter salary data. Most workers in this role earn between $285,200.00 and $353,000.00 per year, depending on experience, location, and employer.

What is a remote director statistical programming?

A Remote Director of Statistical Programming is a senior-level professional who oversees statistical programming teams and projects, often within the pharmaceutical, biotechnology, or clinical research industries, while working remotely. They are responsible for ensuring the accuracy and efficiency of statistical data analysis and reporting, particularly for clinical trials and regulatory submissions. This role involves managing programmers, developing programming standards, ensuring compliance with regulatory requirements, and collaborating closely with statisticians, data managers, and project leaders. Working remotely, they utilize digital tools to lead distributed teams and maintain high-quality data deliverables. Their work is critical in transforming raw clinical data into meaningful insights for decision-making and regulatory approval.

What are the key skills and qualifications needed to thrive as a remote director statistical programming?

To thrive as a Remote Director Statistical Programming, you need advanced expertise in statistical programming (typically SAS and R), a strong background in biostatistics or related fields, and significant experience in clinical trial data analysis, usually supported by a relevant degree. Mastery of programming tools, regulatory submission standards (such as CDISC SDTM/ADaM), and familiarity with data management systems are crucial, along with relevant certifications being advantageous. Leadership, strategic thinking, and exceptional communication skills help you effectively manage teams and collaborate across global, cross-functional groups. These skills ensure accurate, regulatory-compliant analyses that drive successful clinical development and organizational goals.

How does a remote director statistical programming typically collaborate with cross-functional teams while managing geographically dispersed staff?

A Remote Director of Statistical Programming often leads a team of programmers who may be distributed across different locations and time zones. Collaboration with cross-functional teams—such as biostatisticians, data managers, and clinical operations—relies heavily on clear communication through virtual meetings, shared project management tools, and regular status updates. The director is responsible for aligning programming deliverables with project timelines, ensuring quality standards, and fostering a cohesive team environment despite the remote setup. Strong leadership and proactive engagement are essential to overcome challenges like time zone differences and maintain alignment with overall project goals.

What is the difference between Remote Director Statistical Programming vs Remote Statistical Programming Manager?

AspectRemote Director Statistical ProgrammingRemote Statistical Programming Manager
CredentialsTypically requires advanced degrees (e.g., MS, PhD) and extensive experienceRequires similar degrees and experience, but slightly less senior
Work EnvironmentLeadership role overseeing multiple teams, strategic planningManages teams directly, focuses on project execution
Industry UsageCommon in large pharma and biotech companiesFound in similar settings, often as a mid-level leadership role
Search & Comparison IntentOften searched by senior professionals or recruitersMore frequently searched by mid-level managers or job seekers

The Remote Director Statistical Programming is a senior leadership role overseeing multiple teams and strategic initiatives, requiring extensive experience and advanced degrees. In contrast, the Remote Statistical Programming Manager focuses on managing project teams and day-to-day operations. Both roles are vital in pharmaceutical and biotech industries, but they differ mainly in seniority and scope of responsibilities.

What are popular job titles related to Remote Director Statistical Programming jobs in Fremont, CA?

For Remote Director Statistical Programming jobs in Fremont, CA, the most frequently searched job titles are:

What job categories do people searching Remote Director Statistical Programming jobs in Fremont, CA look for?

The top searched job categories for Remote Director Statistical Programming jobs in Fremont, CA are:

What cities near Fremont, CA are hiring for Remote Director Statistical Programming jobs?

Cities near Fremont, CA with the most Remote Director Statistical Programming job openings:

Statistician, CMC (Chemistry, Manufacturing, and Controls)

Menlo Park, CA • On-site, Remote

Orca Bio
Pharmaceutical and Medicine Manufacturing • 51 - 200 employees

$100K - $160K/yr

Full-time

Posted 20 days ago


Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Position Summary:  We are seeking a skilled Statistician to join our CMC organization and provide statistical leadership across analytical method development, validation, comparability, and product characterization activities. The successful candidate will partner closely with Analytical Development, Process Development, and Validation teams to design studies, analyze complex data (including non-normal distributions common in biologics assays), and translate results into clear, regulatory-defensible conclusions that support process and product decisions across the product lifecycle. In this role, you will provide hands-on statistical expertise across the full product lifecycle, from early analytical method development through commercial manufacturing, ensuring compliance with ICH, FDA, and EMA guidance.
Essential Duties & Key Responsibilities
  • Design and execute comparability assessments for process changes, site transfers, scale- up/scale-down activities, and reference standard qualification, utilizing equivalence testing, quality range methods, and mixed-effects models to establish pre-specified acceptance criteria.
  • Develop and apply tolerance interval methodologies (parametric, non-parametric, and distribution-free approaches) to establish specifications, in-process control limits, and shelf- life/stability ranges across the product lifecycle.
  • Conduct Bland-Altman analysis and method-agreement/method-transfer evaluations to assess bias, limits of agreement, and comparability between analytical platforms, instruments, and laboratories.
  • Provide statistical support for analytical method validation and verification, including accuracy, precision, linearity, range, and robustness studies, with particular expertise in handling non- normal and skewed data through transformation strategies and non-parametric methods.
  • Author and review statistical sections of validation protocols, reports, and summary statistics packages suitable for regulatory submissions (BLA/MAA/NDA, CTD Module 3) and responses to health authority queries.
  • Develop, validate, and maintain statistical code and templates (R, SAS, JMP, Python) to ensure consistency, traceability, and reproducibility of analyses; stay current with ICH, FDA, and EMA guidance on comparability, analytical procedures, and statistical methods.
  • Collaborate with Analytical Development, Process Development, QC, and Regulatory Affairs to design fit-for-purpose experimental designs (DOE), sampling plans, and risk assessments while communicating statistical concepts clearly to non-specialist stakeholders.
Experience & Education
  • B.S., M.S., or Ph.D. in Statistics, Biostatistics, Applied Mathematics, or a related quantitative field (or equivalent experience).
  • 6+ years (B.S.), 3+ years (M.S.), or 1+ years (Ph.D.) of relevant industry experience applying statistics within a CMC, analytical development, or QC environment in biotech/pharma.
  • Demonstrated hands-on experience with comparability assessment methodologies for biologics or small molecules, tolerance interval construction (parametric and non-parametric), and Bland- Altman/method-comparison techniques.
  • Demonstrated experience providing statistical support for analytical method validation, including strategies for non-normal/non-Gaussian data, robust statistics, and bootstrapping methods.
  • Proficiency in a statistical programming language (JMP preferred; R, SAS, Minitab, or Python also relevant).
  • Working knowledge of relevant ICH Q2(R2), Q14, FDA, and EMA guidance related to analytical procedures, comparability, and specification setting.
  • Strong written and verbal communication skills with ability to explain statistical reasoning to cross-functional, non-statistical audiences.
  • Excellent attention to detail and ability to manage multiple concurrent projects in a fast-paced, highly regulated environment.
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
 
Who we are
 
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
 
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
 
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
 
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
 
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
 
Notice to staffing firms
 
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.