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Sr. Director Biostatistics

Employer
Olema Oncology
Location
San Francisco, California
Start date
Nov 17, 2023

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

Job Details

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

Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 2 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.

Onto something big, 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. 

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.  

In this hands-on position reporting to the Vice President 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, statistical programmers, data managers, 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 office and will require 10% travel. 

Your work will primarily encompass: 

  • Serve as biostatistics lead in designing clinical trials and leading data analyses
  • Apply innovative approaches to study design, analysis methodologies, data exploration, and presentation
  • Provide statistical inputs to protocols, data monitoring committee (DMC) charters, clinical study reports (CSR) and other study-level documents, in collaboration with the study team
  • Author relevant sections of regulatory submissions, documents, responses, and address comments by IRB/ECs
  • Author statistical analysis plan, TLF shells and table of contents for outputs to be generated
  • Accountability for statistical activities in support of regulatory submissions/interactions
  • Collaborate with multi-functional groups on IB, DSUR, CSR, integrated efficacy/safety summaries, external presentations, and publications
  • Review ADaM specifications and verify primary and key secondary efficacy endpoints
  • Oversee programming of ADaMs and TLFs for the study 
  • Validate/QC key study endpoint analysis and submission deliverables 
  • Effectively manage CRO to ensure high-quality deliverables within timeline and budget 
  • Review CRFs, CRF edit checks, CRF completion guidelines, and data management plan 
  • Responsible for one or more studies with concurrent tasks and timelines 

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: 

  • Knowledge of appropriate regulations, industry standards and guidance documents 
  • Broad and thorough understanding of statistical principles and clinical trial methodology; ability to practice and implement statistical principles and methodology 
  • Ability to interact effectively with biostatistical, data management, operations, and clinical personnel internally and from CROs 
  • Knowledge of CDISC and SDTM/ADaM specifications 
  • Strong SAS programming skill  
  • Able to guide the successful completion of major programs and projects 
  • Strong analytical and communication skills 
  • Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies 

Experience: 

  • 8+ years (with PhD degree) or 10+ years (with master’s degree) in biotech/pharmaceutical industry
  • Late-stage development experience in oncology (design and execution of registrational phase 3 studies)
  • Experience in interactions with regulatory agencies; prior record of regulatory submissions and approvals in oncology is preferred
  • Experience in management of CROs with respect to conduct and analysis 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
  • Leading or managing 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 partnerships 
  • Statistical expertise and experience in managing the activities of clinical trials  
  • Ability to develop innovative/creative statistical and technical solutions to complex problems 
  • 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 $240,000-$297,000 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-MK1

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.

Additional Note/Fraud Alert:  Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.

Company

We exist to develop therapies that offer the potential to improve outcomes for women living with cancer. We approach these goals with a single-minded focus.

At Olema Oncology, we leverage our deep understanding of endocrine-driven cancers, nuclear receptors and mechanisms of acquired resistance with the goal of transforming the standard of care for women living with cancer by focusing on developing more convenient and effective therapies. Join us as we aim to design therapies for improving lives.

Why Join Us?

We 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 provide equal opportunity to all employees and applicants for employment and offer competitive compensation and benefits.

Olema seeks to provide an open, flexible, and friendly work environment to empower people and to provide them with a platform to develop their long-term careers.

Located in Cambridge, MA and San Francisco, CA

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Company info
Website
Location
780 Brannan Street
San Francisco
California
94103
United States

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