The Role
Lead statistical programming activities on clinical development programs, manage programming teams, ensure quality deliverables, and support regulatory submissions.
Summary Generated by Built In
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is seeking a Senior Manager or Associate Director of Statistical Programming to lead statistical programming activities across complex clinical development programs. This role oversees high-quality, on-time delivery of datasets, TLGs, and regulatory submissions, manages and develops programming teams and vendors, and serves as the programming lead on key studies. The position partners closely with biostatistics and cross-functional teams to support study design, regulatory readiness, and continuous improvement of programming standards and processes, and can be based in Sugar Land, TX, Princeton, NJ, or Redmond, WA.
This is a bilingual role in Chinese and English.
Responsibilities
SystImmune is seeking a Senior Manager or Associate Director of Statistical Programming to lead statistical programming activities across complex clinical development programs. This role oversees high-quality, on-time delivery of datasets, TLGs, and regulatory submissions, manages and develops programming teams and vendors, and serves as the programming lead on key studies. The position partners closely with biostatistics and cross-functional teams to support study design, regulatory readiness, and continuous improvement of programming standards and processes, and can be based in Sugar Land, TX, Princeton, NJ, or Redmond, WA.
This is a bilingual role in Chinese and English.
Responsibilities
- Responsible for statistical programming activities within a therapeutic project or equivalent
- Lead, manage, develop and support statistical programming team
- Manage critical deadlines, demonstrate ability to problem solving, and ensure quality statistical programming deliverables will be completed within designated timeframe.
- Serve as project leader on studies or tasks of greater complexity
- Attend multi-disciplinary team meetings, representing the statistical programming function.
- Create or review and approve programming plans at study and project level.
- Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
- Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
- Assist statisticians by suggesting algorithms to address novel analysis requests
- Develop software validation procedures and test plans, as necessary.
- Create and document archives of software, outputs, and analysis files.
- Contribute to the creation and maintenance of department SOPs related to clinical data analysis.
- Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
- Oversee work of internal contract programmers and external vendors.
- Provide time and resource estimates for project planning.
Requirements
- BSc or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)
- Preferably at least 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development
- At least 5 years of experience as a statistical programming team leader or manager
- Fluency in English and Chinese
- Strong knowledge of relevant regulatory (FDA, NMPA, EMA, PMDA etc.) and data submission guidelines
- Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions
- Consistent experience as a lead statistical programmer on several concurrent NDA projects
- Strong knowledge of the relevant therapeutic areas and CDISC standards
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer management
- Strong project management skills
Compensation and Benefits:
The expected base salary range for this position is $150,000 - $200,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
The expected base salary range for this position is $150,000 - $200,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
Top Skills
Cdisc Standards
Drug Development Software
Programming Languages
Statistical Programming
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The Company
What We Do
Located in Redmond WA, founded in 2014, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
