Associate Director, Statistical Programming

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Full Remote
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Offer summary

Qualifications:

B.A. / B.S. with at least 15 years of experience or an M.S. with at least 10 years of experience in statistical programming for clinical trials., Proficient in SAS and experienced in creating post-EDC datasets (SDTM and ADaM)., Strong organizational and time management skills, with attention to detail and high standards of work., Excellent interpersonal and communication skills, with experience managing junior programmers as a plus..

Key responsabilities:

  • Ensure accuracy of post-EDC datasets and perform quality control validation using SAS programs.
  • Collaborate with biostatisticians and Clinical Data Management to support data collection and analysis.
  • Manage study-level programming deliverables and timelines in collaboration with study leads.
  • Provide mentorship and support to junior statistical programmers and maintain programming best practices.

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Neumora Biotech: Biology + Technology Scaleup https://www.neumoratx.com/
51 - 200 Employees
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Job description

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.

The Associate Director, Statistical Programming provides support to compounds from clinical development to regulatory filing to commercialization. Reporting to the Director, Statistical Programming, they work closely with Biostatisticians and Clinical Data Management colleagues to support Biometrics team deliverables.

Responsibilities:

•    Holds the primary responsibilities of ensuring the accuracy of post-EDC datasets (SDTM and ADaM) creation from reviewing specifications to performing independent quality control validation using own SAS programs
•    Ensures clinical trial data collection and post-EDC datasets are consistent with industry standards and ready for eDATA submission
•    Works closely with biostatisticians using own SAS programs to perform statistical data analysis to support internal decision making, regulatory communication, or drug product commercialization
•    Performs independent quality control validation for analytic outputs delivered by statistical vendors or by colleagues in Neumora’s Biometrics team
•    Works closely with Clinical Data Management colleagues to produce systematical data reports to support effective clinical trial data review and cleaning
•    Works directly with study team members in Clinical Development and Clinical Operations to provide programming to address data-related questions and to support identification of protocol deviations
•    Manages study-level programming deliverable timeline in collaboration with study lead biostatistician
•    Manages statistical computing environment from folder structure to access control
•    Follows good programming practices and internal program validation process
•    Provides mentorship and support to junior level statistical programmers

Qualifications:

•    B.A. / B.S. with at least 15 years of experience or an M.S. with at least 10 years of experience in using statistical programming to support clinical trials in pharmaceutical/biotech or CRO setting
•    Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro language, and commonly used procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED)
•    Rich experience in following pharmaceutical data standards to create post-EDC datasets (STDM and ADaM) and to create DEFINE packages for eDATA submission to support regulatory filing
•    Strong organizational skills and time management skills
•    Detail-oriented and holds high standards of excellence for work product
•    Effective in delivering in the work-from-home environment
•    Excellent interpersonal skills, an effective communicator, and a good team player
•    Experience with Python to integrate study-specific details with existing files to assist with periodic data review is a plus
•    Experience managing junior statistical programmers to deliver is a plus

2025 Company benefits include:

Medical, dental, vision, and life insurance
401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
Company Equity (New Hire Awards, Annual Awards, ESPP)
Annual paid time off:
Accrued Vacation Days: 15 days per year
Sick Days: 10 days per year
Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed.  Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $190,800-$208,023

Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Required profile

Experience

Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Data Reporting
  • Quality Control
  • Mentorship
  • Communication
  • Time Management
  • Teamwork
  • Organizational Skills
  • Detail Oriented

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