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Associate Director, Biostatistics

Employer
Olema Oncology
Location
San Francisco, California
Start date
Jan 8, 2023

View more

Discipline
Science/R&D, Biostatistics
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Bay

Who We Are >>> Why You Should Work With Us

Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.

Onto something bigger, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer. 

Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts

Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses. 

While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.  

About the Role >>> Associate Director, Biostatistics 

As the Associate Director reporting to the Executive Director of Biostatistics, you will apply your technical expertise and experience to provide recommendations on statistical design and conduct of clinical trials of all phases. You will use your initiative to develop, maintain and share knowledge of appropriate statistical methods for data analysis and clinical trial design, and work collaboratively across disciplines with clinicians, data managers, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.  

This role is based out of our San Francisco, CA or Cambridge, MA offices and will require 20% travel. 

Your work will primarily encompass: 

  • Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications 
  • Author statistical analysis plan, TLF shells and table of contents for outputs to be generated 
  • Review ADaM specifications and verify primary and secondary efficacy endpoints 
  • Oversee programming of ADaMs and TLFs for the study 
  • Effectively manage CRO to ensure high-quality deliverables within timeline and budget 
  • Review CRFs, CRF edit checks and CRF completion guidelines 

And will also include: 

  • Work with project team members on developing clinical protocol 
  • Responsible for one or more studies with concurrent tasks and timelines 
  • Participate in the validation/QC of key study endpoint analysis and submission deliverables 
  • Apply appropriate regulatory guidelines to the projects 
  • Aid in establishment of internal biostatistics processes and procedures 

Ideal Candidate Profile  >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

  • MS or PhD in statistics or related discipline 
  • Knowledge of appropriate regulations, industry standards and guidance documents 
  • Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs 
  • Development and review of SDTM/ADaM specifications 
  • Strong SAS programming knowledge  
  • Able to guide the successful completion of major programs and projects 
  • Applies strong analytical and business communication skills 
  • Broad and thorough understanding of statistical principles and clinical trial methodology; ability to practice and implement statistical principles and methodology 
  • Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies 
  • Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas 

Experience: 

  • 6+ years (with PhD) or 8+ years (with MS) in biotech/pharmaceutical industry 
  • Experience in oncology across all phases of development required 
  • Experience in management of CROs with respect to conduct and analysis of clinical trials 
  • Experience with statistical applications and clinical data management procedures in the conduct of clinical trials  
  • Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework 
  • Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing   
  • Utilizing broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways 

Attributes: 

  • Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflict resolution, and effective partnership 
  • Statistical expertise and experience in managing the activities of clinical programs  
  • Ability to develop innovative/creative statistical and technical solutions to complex problems 
  • Demonstrates strong verbal and written communication skills 
  • Ability to effectively represent Biostatistics in multidisciplinary meetings 
  • A commitment to excellence   
  • Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
  • Have impeccable professional ethics, integrity and judgment

The base pay range for this position is expected to be $203,000 - $215,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-CK1

Important Information >>>

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

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