Statistical Programmer/Senior Statistical Programmer

Mountain View, CA /
Clinical Research & Development – Biometrics/ Clin Data Management /
Full-Time
/ Hybrid
About IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases, and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology, and inflammation targets. For more information, please visit www.igmbio.com.

IgM Antibodies and Autoimmune and Inflammatory Diseases
Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases, and IgMs are the first antibody defense against a pathogen infection.  We are committed to exploring how the unique structure and binding properties of our IgM platform can improve outcomes for patients with these serious conditions.

IgM Antibodies and Oncology
IGM Biosciences has a T cell engager program, a receptor cross-linking agonist program and a targeted cytokine program in clinical studies for the treatment of patients with solid tumors and hematological malignancies.  

Responsibilities:

o Individual contributor for one or multiple studies, managing all aspects of study deliverables related to statistical and clinical programming.
o Represent the statistical programming team at CST meetings to address deliverables and timelines.
o Conduct statistical programming for data review listings, CSR, ad hoc analyses, external presentations, publications, DSUR, IB, safety data review, etc.
o Familiar with SDTM and ADAM structures and variable specs.
o Solid programming skills for SDTM, ADaM, and TFLs.
o Profound knowledge for regulatory submissions following CDISC standards.
o Work with head of programming and collaborate with multiple functions to maximize automation processes for data extraction, reconciliation, data review listings, and patient profiles to expedite clinical data review and cleaning.
o Review key study-related documents including but not limited to SAP, annotated case report form, data management plan, database specifications, and EDC data structures.
o Other duties as assigned.

Qualifications:

o Bachelor or Master's Degree in Statistics, Life Sciences, Computer Science, or related fields with 2 - 4 years of clinical/statistical programming experience in the pharmaceutical/biotech industry.
o Experience in both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings.
o Mid-level SAS programmer with experience in delivering complex programming assignments, macros, and analyses. Experience with R/Spotfire is a plus.
o Experience with Autoimmune/oncology/hematology trials is preferred.
o Experience with BLA, NDA/sNDA to FDA/EMA is a plus.
o Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
o Ability to manage and execute multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
o Excellent verbal and written communication skills.


The typical annual salary range for this full-time position is $110,000 - $170,000, plus eligibility for cash and equity incentives.

This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.

Actual individual pay is determined by demonstrated experience and internal equity alignment.
We offer a fast-paced, collaborative, team-based, and family-like work environment.
One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
·       Medical, dental and vision insurance.
·       The full premium amount for our employees and their dependents is covered by IGM
·       FSA (Flexible Spending Account)
·       STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
·       401(k) Plan
·       120 hours of Paid Time Off, 5 sick days per year, 10 holidays
·       Cell phone & internet subsidy
·       Employee Referral Bonus Program
·       Annual training budget for professional development
·       Commuter Benefit
·       Annual bonus program
·       New hire stock options
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment. 


The typical annual salary range for this full-time position is $110,000 - $170,000, plus eligibility for cash and equity incentives.

This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.

Actual individual pay is determined by demonstrated experience and internal equity alignment.