Associate Director/Director, Biostatistics
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.
The Director/Associate Director of biostatistics will join the Clinical Research and Development Group at IGM Biosciences to drive and support biostatistics efforts for our clinical programs in autoimmune and inflammatory diseases. In this role, you will interact cross-functionally in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical projects. You may also interact with CROs.
Qualifications:
· PhD or equivalent degree in statistics/biostatistics or related discipline with 5+ years relevant work experience, or a Master’s degree with 8+ years relevant work experience. Title will depend on qualifications.
· Experience in autoimmune and inflammatory diseases drug development is preferred.
· Experience with regulatory interaction is preferred.
· Solid knowledge of statistical analysis methodologies and experimental design from phase I to IV.
· Solid knowledge of statistical and data processing software of SAS and/or R.
· Strong project management skills.
· Excellent verbal and written communication skills.
· Ability to manage and execute multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
· Able to engage in work-related travel as needed.
Responsibilities:
· Serves as statistical representative at project team for the strategic planning of product development and execution of projects.
· Ensures that study designs are consistent with program objectives and meet regulatory and commercial needs.
· Develops protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
· Analyzes data and interprets results from clinical trials to meet objectives of the study protocol and analysis plan.
· Prepares written reports and/or slide deck to effectively communicate study results to the project team, management team, or investigators.
· Collaborates with multi-functional groups on IB, DSUR, CSR, integrated efficacy/safety summaries, external presentations, and publications etc.
· Provides responses to queries relating to study design, analysis, and interpretation of results from the IRB, EC, regulatory agencies, or investigators.
· Manage and mentor junior statisticians as needed.
· Other duties as assigned.
The typical annual salary range for this full-time position is $175,000 - $240,000, 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, work environment.
One of our top priorities is to maintain the health and well-being 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, 11 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.